Jazz Pharma Loses Fibromyalgia Drug Approval, Still on our Top Pharmaceutical Stocks List

Drug maker Jazz Pharmaceuticals Inc. (NASDAQ: JAZZ) said it failed to get an FDA nod for its JZP-6 (sodium oxybate), a potential treatment for fibromyalgia. The U.S. health regulator, in its complete response letter, informed the Palo Alto, Calif.-based company that additional clinical studies of JZP-6 would be required and that the agency wanted more information on the appropriate fibromyalgia patient population, methods to ensure the drug’s safe use, dosage and a risk management plan.

Monday’s news did not come as a great surprise given that a joint advisory committee in August voted against the approval of JZP-6 amid risks of drug abuse and accidental overdose. JZP-6 is a close relative of gamma-hydroxybutyric acid (GHB), which has been used as a club drug.

Since 2002, Jazz has been selling JZP-6 as a treatment for sleep disorders under the brand name Xyrem. It also markets Luvox CR (fluvoxamine maleate) for the treatment of both obsessive-compulsive disorder and social anxiety disorder.

Jazz is focused on the development and commercialization of pharmaceutical products to meet unmet medical needs in neurology and psychiatry. Expanding its market to include fibromyalgia would be a significant growth opportunity for the drug maker. Fibromyalgia, one of the most common chronic pain conditions, affects an estimated 10 million people in the United States and an estimated 3-6% of the world population, according to the National Fibromyalgia Association.

Following Monday’s negative FDA decision, the company said it has requested a meeting with the FDA in order to discuss and clarify the contents of the complete response letter and will then evaluate its next steps for JZP-6.

“We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA,” Bruce Cozadd, chairman and CEO of Jazz stated in a press release.

So far JAZZ has reached a 52-week low and high of $6.01 and $13.95, respectively. It has a consensus recommendation of Outperform.

FDA Rejects GHB for Fibromyalgia

The FDA has told Jazz Pharmaceutical it can't approve sodium oxybate (JZP-6), also known as GHB, in its current form for treating fibromyalgia.

The FDA listed a number of reasons for the decision, including the need for additional clinical studies, and the need for methods to ensure its "safe use," according to a company press release.

In August an FDA advisory panel voted 20-2 against approval of the drug for a fibromyalgia indication.

The Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee felt the potential for widespread abuse of the "date rape" drug was too great to warrant expanding the indication to a condition that affects an estimated 2% of the U.S. population.

Sodium oxybate, currently approved as Xyrem at a 500 mg/ml dose for narcolepsy-associated cataplexy and excessive daytime sleepiness, is a central nervous system depressant and carries a boxed warning against its use in combination with other similar drugs.

The label information also warns that sodium oxybate is a drug known to be abused. Sodium oxibate is a sodium salt of y-hydroxybutyrate, or GHB.

The committee examined the company's two randomized, double-blind, phase III trials testing sodium oxybate versus placebo.

In FDA documents released in advance of the August panel meeting, FDA reviewers said there was "no question" the drug was effective, but advisory committee members weren't so sure.

Also, panelists were concerned about the drug's odd dosing mechanism, as was the FDA. The drug has an extremely short half-life, so patients must take one dose of a self-mixed solution at bedtime, and set their alarm clocks to wake up and take a second dose four hours later.

Patients taking the drug pass out almost immediately, with no time to even "send an e-mail" as another patient put it.

The dosing apparatus also has the potential for confusion, panelists pointed out. Patients must empty a solution into a small cup and mix it with water. Several people in the study accidentally took a double dose.

GHB was sold without a prescription in health food stores until 1990 when it was classified as a controlled substance by the FDA.

Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals, said his company has requested a meeting with the FDA to discuss the agency's denial.

"We continue to believe there is a significant unmet medical need among fibromyalgia patients that could be met by JZP-6 if it were approved by FDA," Cozadd said in the press release.

Products Seized from Caraco Pharmaceutical Labs

After continued failure to adhere to the U.S. Food and Drug Administrations (FDA) Good Manufacturing Practice requirements, the U.S.Marshalls seized all of the drug products and materials that were found in the Caraco Pharmaceutical Labs Ltd. Caraco has three locations in Michigan – Detroit, Farmington Hills and Wixom. The Center for Drug Evaluation and Research is committed to protecting the public from companies who do not adhere to the safe and hygienic guidelines that are set by the FDA.

The company has enacted its own voluntary recalls of products since January 2009 as it became aware of inconsistencies in the production of some of its drugs. These inconsistencies were evident in some tablets that were oversized which in turn affected the correct dosage for effective treatment.

A warning letter was sent to Caraco on October 31, 2008 that discusses in detail all of the violations that this company is accused of and has ignored to date. Failure of quality control is elaborated on as serious inconsistencies in the production of drugs were discovered from the above mentioned facilities. Cross contamination of products was found, incorrect levels of certain medications that should be included in some of the medications were noted and failure to put certain products on hold because of manufacturing problems was also addressed.

The Caraco plants manufacture over 33 different drugs in a variety of strengths. The FDA seized all of the drugs as well as the ingredients that are used to produce the drugs. Of all of the products seized, the FDA is concerned that there could be a shortage of one of the products, choline magnesium trisalicylate which is used as a general pain reliever. The other medications are listed on the FDA site and are not expected to cause a shortage because of the confiscation as other pharmaceutical companies produce the same products.

Some of the more commonly used products manufactured by Caraco that have come under fire include Metformin, which is used by patients with type 2 diabetes to control blood sugar levels, Clozapine, which is administered as an anti-psychotic treatment for patients who suffer from schizophrenia, and Oxaprozin, which is used to treat inflammatory joint pain caused by osteoarthritis and rheumatoid arthritis.

Just the three examples listed above open up the possibility of complications as a result of the violations that have been confirmed at the Caraco manufacturing plants. Inconsistent doses that relate to any of the above conditions could result in serious side affects.

A diabetic who is not receiving a high enough dose or a too low dose of metformin can be affected directly through the effects it has on his or her blood sugar levels. An incorrect dose of medication that is administered to someone who is being treated for physcotic episodes could quickly become life threatening. And uncontrolled joint pain could be experienced by patients who suffer from both types of arthritis.

If you currently take or have taken in the past any medications manufactured by the Caraco companies, and have experienced any complications as a result, contact our law firm, Napoli, Bern Ripka, at 1-888-LAW-IN-NY. Our attorneys have experience in helping victims receive compensation for becoming victim to the negligence of major pharmaceutical manufacturers.

F.D.A. Rejects Savient’s Gout Drug

The Food and Drug Administration has declined to approve a gout drug developed by Savient Pharmaceuticals, the company said on Sunday.

The decision was in spite of a 14-1 recommendation for approval by an F.D.A. advisory committee in June. Shares of Savient are likely to tumble on Monday.

Savient, based in East Brunswick, N.J., said it hoped it could resubmit its application for approval of the drug, called Krystexxa, early next year.

Gout is a painful form of arthritis that appears to be on the increase, in part because of richer diets, obesity and the aging of society. Savient had hoped Krystexxa would be the second new drug approved for the disease this year, after a drought of more than 40 years.

The F.D.A.’s decision appeared to be based not on concerns about the drug’s effectiveness but on Savient’s manufacturing process, according to the company’s news release.

The agency concluded that a proposed change in the manufacturing process might make the marketed product different from the experimental product used in the clinical trial.

The agency also said that Savient would need to have a program to monitor and reduce the side effects of the drug, particularly allergic reactions and cardiovascular problems.

The F.D.A. typically does not discuss such regulatory decisions. Even if Krystexxa had been approved, it had competition.

On Thursday, the F.D.A. approved a drug called Colcrys, made by Mutual Pharmaceutical, to treat gout flares. The F.D.A.’s action was part of an effort to formally approve drugs that have been used for a while without thorough regulatory review.

K'taka drugs dept serves show cause notices to 236 pharmacies, cancels 3 mfg licenses

India, Karnataka drugs control department has served show cause notices on 236 pharmacy outlets in the state during last month. It has also suspended 110 sales licenses and cancelled 88 licenses. The action is subsequent inspections carried out by a team of enforcement officers during the month.

The cancellations of licenses were done as these establishments were found to have violated provisions of Rule 65 of Drugs & Cosmetics Act. During the time of inspection and on analysis, the drugs were found to be not-of-standard quality and the outlets are implicated for the alleged infringement of the Act. The Department has cancelled three manufacturing licenses besides issuing three show cause notices and one stop production order.

The department has also issued 279 fresh licenses and two new drug manufacturing licenses.

During the month, the department has filed two cases for prosecution in the court. Of the six earlier cases, four were convicted. From the public, the department received 10 complaints which are being investigated.

In its efforts to contain manufacture and sale of drugs of not-of-standard quality or misbranded or adulterated, the drugs inspectors collect certain number of samples every month from the market. Periodic raids are conducted under the supervision of state drugs controller or the assistant drugs controller or senior drugs inspectors. The seized drug samples are analysed at the in-house drug test lab in Bangalore. In June, drug test lab received a total of 304 samples for analysis and had 13 products declared as not-of-standard quality and investigation is being carried out. These included Rabes, Raberprazole tablets manufactured Alliance Biotec and Orazep -Z : Lorazepam tablets by Mission Laboratories at Baddi in Himachal Pradesh.

There are also two Karnataka companies which have been issued notices for not-of- standard quality. These are Embiotic Laboratories for Dicyclomine tablets and Karnataka Antibiotics & Pharmaceuticals Ltd for Nufenac which is a Diclofenac sodium tablets.

Other companies are Rexer Pharma at Hyderabad for Ciprex (ciproloxin hydrocholride) and Chennai based Sai Mirra Innopharm for Durandil tablets.

There are 22,520 pharmacy sales outlets, 173 blood banks, 29 blood storage centres, 230 drug manufacturing companies and 92 cosmetic manufacturing units in the State. Over the last 30 days, the enforcement officers have carried out 1,753 inspections of retail outlets, 27 inspections of blood banks and 25 inspections of manufacturing units.

Karnataka DC raids chemists, seizes huge stocks of substandard drugs made outside state

India, Karnataka drugs control department has seized drugs not-of-standard quality medicines sold at chemist outlets in the State. The drug test lab which conducted the analysis of the drugs has found that medicines were found non compliant with the analysis.

The drugs have been manufactured mostly by companies outside the state. These include companies from the excise free zone at Baddi in Himachal Pradesh.

The reasons for drugs not being of standard quality are inadequate quantum of active ingredients, non compliance with the requirement of sterility, disintegration, assay requirements, weight uniformity and presence of undesirable substances. Companies need to maintain the highest quality of manufacture and have to ensure re-checks at every stage to avoid getting into this situation, stated Dr BR Jagashetty, Karnataka drugs controller.

"We have alerted the pharmacy outlets, hospitals and nursing homes in the state not to sell or stock these drugs. The public have also been alerted to avoid purchase of these drugs which are available over-the-counter", he added.

United Biotech at Baddi has been engaged in the manufacture of Unifolin 50, Leucovorin Calcium injection. Goran Pharma located in the Gujarat Industrial Area was engaged in the production of Chlorhexidine mouth wash, Perix. Cooper Pharma in Delhi has been intimated for its enteric coated Aspirin. Enpala Laboratories located in the Industrial Area at Lokokere Road, Davengere in Karnataka manufactured Enpestine Expectorant which has been found lacking in the quality of contents.

Waksman Selman Pharmaceuticals Pvt. Ltd. has been producing Ciprofloxin in 250 mg strength which has been listed in the not-of-standard quality list. Oflocacin tablets sold under the brand name Ocinol was manufactured by Biotech Pvt. Ltd at Vadodara and Gentamic injection under brand name Lytamycin manufactured by Parenterals Pvt. Ltd. at Tetali, Andhra Pradesh are also in the list. Modern Laboratories which manufactures Cyanocobalamin injection (Vitamin 12) and Elmac Remedies (P) Ltd manufacturing Kufmac tablets also figure in the list of poor quality makers. All these drugs are being sold in outlets in the state.

The not-of-standard quality drugs are being produced largely by small scale manufacturers. These drugs are not found to be in compliance with IP/USP standards. The problem of discoloration and fungus infestations are serious issues associated with the drugs produced by the units across the country.

In yet another raid of some chemist outlets, the Special Court of Economic Offences has convicted the proprietor of Sri Ram Medicals for stocking the drugs marked as 'ESI Supply Not for Sale'. The accused has been convicted and will undergo simple imprisonment.

K'taka drugs dept seizes 4000 physician samples & low quality medicines

Swooping down on the violators of the Drugs and Cosmetics Act, the Karnataka drugs control department has seized around 4,000 physician samples from a pharmacy outlet in Shimoga district. Medicines worth Rs 3 lakh were also seized from an unlicensed premise at Gadag in north Karnataka.

The United Biotech located at Baddi has been engaged in the production of not-of- standard quality drugs and these have been seized in Karnataka. These drugs valued at Rs 9 lakh include Unifoli and Lucuverin injections.

Last month, the department had issued show cause notices for various violations detected at the manufacturing and sales premises. The enforcement officers carried out 1803 inspections on sales premises, 12 inspections on blood banks and 25 inspections on manufacturing units. It has suspended 87 sales licenses and cancelled 30 sales licenses. It has filed nine prosecution cases filed in the court. In the same period, eight cases were disposed of which five were convicted. Of the 16 cases received from the public are now being investigated.

In drug testing laboratory, a total of 319 samples were analyzed of which 22 samples were declared not-of-standard quality and investigations are being carried out.

Counterfeiting of pharmaceutical products and the proliferation of substandard drugs constitute a serious health risk for the public. There is a need to curb this practice and that is where the inspectors are on the constant vigilance drive, Dr BR Jagashetty, Karnataka drugs controller told.

The state has around 22,425 sales premises, 172 blood banks and 231 manufacturing unit. The drugs department with a view to bring about improvement in systems in order to tackle the malpractices conducts surprise inspections. Besides, it has also made it mandatory to manufacturers and pharmacy outlets to provide details of the products during assessments.

Further, the department also considers complaints from the public as a vital source of information. There is also a complaint handling process in place. The effort is to eradicate the unethical practices and bring about transparency. As the department is facing an acute shortage of manpower, the state government has sanctioned 370 posts, stated Dr. Jagashetty.

This increase in number of staff will help the drugs control department to continue its regular inspections which is the only way to deter malpractices. This can enhance the credibility of the manufacturers and the pharmacy outlets in the state, he added.

FDA denies approval of King, Acura's pain drug

* FDA issues complete response letter to the two cos

* Raises questions on the drug's abuse-deterrent properties

* Cos believe can address issues without additional trials

* Acura shares fall as much as 15 pct, King down 3 pct (Adds analyst comments; updates stock movement)

BANGALORE India, - Acura Pharmaceuticals Inc (ACUR.O) and King Pharmaceuticals Inc (KG.N) said U.S. health regulators denied approval of their pain drug, Acurox, and raised questions on the potential abuse-deterrent benefits of the drug.

The companies, which were issued a complete response letter by the U.S. Food and Drug Administration, said they expect to respond to the issues raised in the letter without conducting any additional studies.

"This is all that Acurox is, its abuse-deterrent. And now there are questions about what FDA thinks about those benefits. It sounds pretty bad," Biologic Investment Research analyst Kevin McNamara said.

McNamara, who has a "sell" rating on the stock, said it is highly unlikely that the drug might even get approved as a branded generic form of oxycodone.

Late last month, Acura had received a preliminary review letter from FDA, and said that based on that letter it was no longer expecting an approval by the June 30 action date. Acurox, which includes the powerful pain reliever oxycodone, contains components designed to thwart prescription drug abuse, which can be common with opioid pain drugs.

The FDA had said in February that it wanted manufacturers to take stronger measures to prevent misuse and abuse of long-acting and sustained-release opioids, a class of powerful, highly addictive narcotics prescribed to relieve chronic pain.

Apart from Acurox, Acura has two more pain drugs, Acuracet and Vycavert, in the pipeline, and they are also designed to resist common methods of abuse through intravenous injection of dissolved drugs, nasal snorting of crushed tablets or swallowing in excess quantities.

"The other pipeline drugs are essentially the exact same thing (abuse-deterrent painkillers). So today's news can apply to their entire portfolio," Biologic Investment's McNamara said.

Shares of Acura fell to a low of $5.01 but pared losses to trade up 6 cents at $5.97 Thursday morning on Nasdaq. King shares were down 3 percent at $9.53 on the New York Stock Exchange.

Your Company Has Been Raided. What Now?

Investors in a highly regulated industry like drug development need to be conscious of what the regulators, the Food and Drug Administration in this case, are up to. Usually we're worried about the companies we invest in getting their drugs approved, but lately investors have had to worry about companies keeping their drugs on the market.

Two weeks ago, the agency told Matrixx Initiatives to stop marketing its Zicam Cold Remedy products. Last week it sent U.S. marshals to seize drug products manufactured by generic-drug maker Caraco Pharmaceutical Laboratories (NYSE: CPD).

The FDA said Caraco had repeatedly failed to comply with good manufacturing practice requirements and the seizure was made to keep Caraco from distributing drugs manufactured at one site until it resolves the issue. In total, the seized drugs may have been worth $15 million to $20 million -- a considerable sum for a company that had inventory of just $80 million at the end of the fiscal year that ended in March.

The seizures may help the competition -- generic-drug makers like Teva Pharmaceuticals (Nasdaq: TEVA), Mylan (Nasdaq: MYL), Dr. Reddy's Laboratories (NYSE: RDY), and even the Sandoz division of Novartis (NYSE: NVS) -- but I'm willing to bet that they'd just as soon have not seen one of their competitors go down like this. My guess is that finding violations at Caraco is only going to make the FDA auditors look harder at other drugmakers. In fact, the director of the FDA's Center for Drug Evaluation and Research hinted as much by saying, "The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our good manufacturing practice requirements."

Unfortunately, the average investor can't see these things coming, but there's a simple way to deal with the risk of losing products: diversify. Drug investors can accomplish that by investing in a large pharmaceutical company -- although many are still quite dependent on a single drug -- or by investing in multiple smaller companies.

Just like diversifying to get multiple shots on goal for drug approvals, diversifying to get revenue streams from multiple approved drugs seems like a prudent move in this regulatory environment.

Sun Pharma to come out with revised guidance

Mumbai, India: Sun Pharmaceuticals said on Saturday it would come up with a revised guidance on its performance in the wake of action taken by the US health regulator FDA against Caraco Pharma, its US-based subsidiary.

The US FDA had seized the entire stock of drugs manufactured at the Michigan facility of the Sun Pharma for failing to meet high manufacturing standards. Speaking to analysts at a conference call, Sun Pharma Chairman and Managing Director Mr Dilip Sangha vi said, “As soon as we have clarity, we will give our revised guidance.”

He said that the US FDA action was not the result of any new legislation but only the enforcement of existing laws more forcefully due to some instances which affected US citizens. Mr Sanghavi clarified that the problem was specific to Caraco and Sun Pha rma's other facilities inspected by the FDA do not have any issues.

He said that the action against Caraco was under a Court order and the company would interact with FDA through lawyers to get the issue resolved. He indicated that the FDA action might affect the company in the short term, but there would not be any imp act in the medium-to-long-term.

St hammers Sun Pharma as USFDA seizes 33 drugs of arm

Mumbai, India: US authorities seized drugs made by Sun Pharmaceuticals’ US subsidiary for violation of manufacturing standards, pushing down share

prices of India’s biggest drug company by market value by 12%. US Marshals on Thursday seized nearly 33 drug products, including generic versions of heart, pain and psychiatric medicines, manufactured at three units of Sun Pharma’s US subsidiary, Caraco Pharmaceuticals in Detroit, Farmington Hills and Wixom.

The seizure, which was carried out at the request of the US Food and Drug Administration (USFDA), put immediate halt to the US firm distributing drugs until there is assurance that it complies with the FDA’s current good manufacturing practices (cGMP).

“The action follows Caraco’s continued failure to meet the FDA’s cGMP requirements, which assure the quality of manufactured drugs,” the USFDA said in a media release. “The FDA is committed to taking enforcement action against firms that do not manufacture drugs in accordance with our cGMP,” Janet Woodcock, director of the FDA’s Centre for Drug Evaluation and Research, said in the statement.

Sun Pharma owns about three-fourth of Caraco. “Products manufactured at these facilities contribute around 15% to Sun Pharma’s topline and slightly more to the bottomline. So, in the short term, the impact will be around 15%. However, such issues do not get rectified quickly and I estimate that it will take around three quarters to resolve. It will be a stage by stage recovery,” said an analyst, who did not want to be named due to the sensitivity of the issue.

The Sun management, he said, may consider shifting the production base to other sites and look at other acquisitions, which is a time consuming process. “Over all, Sun’s image has been damaged and it will take Sun Pharma some time to regain it. In the meanwhile, it will lose market share that won’t be easy to recover,” he said. The market reacted sharply. The stock lost 18%, its biggest intra-day drop, during the trading hours.

However, it closed at Rs 1,140.45 on Friday, approximately 12% lower than Thursday’s close on the BSE. Caraco shares, on Thursday, plummeted 43% to an all-time low of $2.39 after the seizure. A Sun Pharma spokesperson declined to comment on the issue. However, it’s learnt that the company will host a conference call for investors on Saturday morning.

“While we have not fully determined the impact of the FDA action on our financial condition, we believe that it may have a material adverse effect on our near-term operations. We anticipate working with the FDA to resolve these concerns as effectively and expeditiously as possible. We believe that corrective actions have been made and continual improvements are in process,” Caraco said in a media statement.

Caraco filed 10 abbreviated new drug applications (ANDAs) with the FDA in FY09 and has 29 ANDAs pending approval by the FDA, which includes

four tentative approvals. The action by the FDA, however, has put all future approvals on hold for the company, casting doubt on the company’s future pipeline of products.

Caraco had earlier disappointed analyst with a drop in annual sales and income for FY09. Net sales dropped 4% to $337.2 million for FY09 as compared with $350.4 million for FY08. Net income decreased to $20.5 million during FY09 compared with $35.4 million in the previous year. Sun Pharma is not the only Indian company to be pulled up by the USFDA in recent times.

In September 2008, the FDA banned Ranbaxy from importing more than 30 generic drugs into the US because of manufacturing violations at its two Indian plants — Ponta Sahib and Dewas. In May this year, the FDA issued a warning letter to Lupin related to quality issues at a company facility in India and also sent queries to Cipla about four of its plants during routine inspections.

Caraco contributes almost 33% to Sun Pharma’s turnover. Of the 33 products manufactured by Caraco, three of its top products contribute almost one-third of its total revenue. Generic versions of Ultracet, made from the active pharmaceutical ingredient (API) Tramadol, has limited competition, as it is a difficult product to make and is likely to take the biggest hit. With the seizure of the drugs, the FDA anticipates that there may be a shortage of choline magnesium trisalicylate oral tablets, another product that is manufactured by Caraco.

This is the latest in a series of investigations against Caraco. A May 2008 inspection revealed serious deficiencies in the control of the company’s manufacturing practices. Since January 2009, Caraco has recalled a number of products due to manufacturing defects, including oversized tablets.

Seizures often lead to court orders that require companies to take steps to correct cGMP violations in their manufacturing processes. These steps may include hiring outside experts, writing new procedures and conducting extensive training to their employees.

FDA Stops Shipments of 33 Generic Drugs from Caraco Plants

WASHINGTON,- Federal marshals dispatched by the FDA have stopped all shipments from three generic drug manufacturing plants in Michigan operated by Caraco Pharmaceutical Laboratories.

The action affects 33 different drugs. It was taken after the company repeatedly failed to correct defects in its manufacturing processes, FDA officials said, despite a warning letter last October and several recalls this year.

Deborah Autor, director of the compliance office at FDA's Center for Drug Evaluation and Research, said the agency's most recent inspection, in May, revealed "serious deficiencies" in the quality control at the plants.

Earlier this year, Caraco had initiated recalls for oversize tablets and formulation errors.

The affected drugs include generic versions of many widely prescribed medications, including the antidiabetic agents glipizide and metformin; high blood pressure meds atenolol, carvedilol, and hydrochlorothiazide; and the psychotropic medications clozapine, clonazepam, and paroxetine.

The company is prohibited from shipping products until the FDA certifies that it is meeting its so-called cGMP quality control standards.

Autor emphasized that patients currently taking drugs produced by Caraco should not stop them. No problems with drugs shipped recently from the plants have come to light, she said.

"All the products we knew to be defective have been recalled [previously]," she said.

She added that the agency would act quickly if it learns of other defects.

In the meantime, the FDA will work with Caraco management to resolve the manufacturing problems.

"Our goal is to get Caraco up and running safely," Autor said. She was unable to say how long that may take.

For one product -- choline magnesium trisalicylate, an oral painkiller -- the action will create a shortage because Caraco has been the sole supplier.

Autor said physicians should look for alternative medications for their patients now on this drug.

Here is the full list of Caraco drugs affected by the seizure:

Allopurinol tablets

Amlodipine tablets

Atenolol tablets

Baclofen tablets

Carvedilol tablets

Cetirizine tablets

Cetirizine IR tablets

Choline magnesium trisalicylate tablets

Citalopram HBR tablets

Clonazepam tablets

Clozapine tablets

Digoxin tablets

Flurbiprofen tablets

Fluvoxamine maleate tablets

Glipizide tablets

Glipizide/metformin tablets

Hydrochlorothiazide tablets

Meloxicam tablets

Meperidine HCl C-II tablets

Metformin tablets

Methimazole tablets

Metoprolol tartrate tablets

Midrin capsules

Mirtazapine tablets

Oxaprozin tablets

Paromomycin sulfate, USP capsules

Paroxetine tablets

Phentermine HCl tablets

Ticlopidine HCl tablets

Tizanidine HCl tablets

Tramadol HCl tablets

Tramadol HCl/acetaminophen tablets

Zolpidem tartrate tablets

Hi-Tech Pharmaceuticals, Inc. Issues Nationwide Recall of All Lots of Stamina-Rx Dietary Supplement Products

FOR IMMEDIATE RELEASE – June 15, 2009 - Norcross, GA - Hi-Tech Pharmaceuticals, Inc. (“Hi-Tech”), 6015-B Unity Dr., Norcross, GA 30071, announced today that it is conducting a nationwide voluntary recall of the company's product sold under the name Stamina-Rx.

On May 1, 2009, Hi-Tech was notified by the Food and Drug Administration (FDA) that FDA's lab analysis of one lot of Stamina-Rx samples found that the product contained the undeclared ingredient − benzamidenafil − a Phosphodiesterase Type 5 (PDE5) inhibitor. The lot number found to contain benzamidenafil is Lot 08141578, Exp. 9/10. Benzamidenafil is in the same therapeutic class of active pharmaceutical ingredients that include the PDE5 inhibitors sildenafil, tadalafil, and vardenafil, that are FDA-approved for the treatment of erectile dysfunction (ED). Benzamidenafil is not FDA-approved, and poses a threat to consumers because benzamidenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be most susceptible to adverse effects from this product.

Stamina-Rx is sold predominantly in health food and drug stores nationwide. The product is sold in 10, 30, and 40-tablet bottles and in 2 and 6-tablet blister packs.

In addition to the one lot described above, Hi-Tech is recalling all other lots of Stamina-Rx because it is an unapproved new drug and misbranded new drug in violation of the Federal Food, Drug and Cosmetic Act (the Act). FDA notified Hi-Tech that, based on certain labeling claims made by the firm, Stamina-Rx is a drug as defined in the Act. Stamina-Rx is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. The labeling at issue was not on bottles of Stamina-Rx, but was contained in certain web-based and print media.

Hi-Tech has been under a Consent Decree of Permanent Injunction with FDA since September 23, 2003. In accordance with the Decree, FDA determined that additional corrective actions were necessary for Hi-Tech to achieve compliance with the Act and the Decree and therefore, on May 1, 2009 FDA ordered Hi-Tech to recall all lots of Stamina-Rx to the consumer level.

Customers who have this product in their possession should stop using it immediately. Any adverse events that may be related to the use of this product should be reported to Hi-Tech Pharmaceuticals, Inc., Norcross, GA 30071 at toll-free 1-888-855-7919 from 9:00 AM - 5:00 PM EST.

The public is encouraged to submit a report of any serious adverse events that occur with the use of Stamina-Rx to FDA’s MedWatch Adverse Event Reporting program online at [www.fda.gov/MedWatch/report.htm] or by phone [1-800-FDA-1088] or by returning the postage paid FDA form 3500 [which may be downloaded from www.fda.gov/MedWatch/getforms.htm] by mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20853-9787 or fax [1-800-FDA-0178].

Chinese drug regulators investigate adverse herbal drug reactions

XI'AN,- A drug producer in northwest China shut down temporarily while authorities investigated claims that its herbal injection caused chills and high fever in some patients, local drug regulators said Monday.

Wang Yongli, spokesman for the Food and Drug Administration of Shaanxi Province, said Xi'an Jiahui Pharmaceutical Co. Ltd. voluntarily closed so that an investigation could be conducted into Shenkang, an injection it produced to treat chronic renal failure.

After receiving injections, 23 patients at the Second Hospital of the Tianjin Medical University in north Tianjin City experienced chills and high fever, said Song Ligang, head of the Center for Adverse Drug Reaction Monitoring of Tianjin. All received prompt treatment and reported feeling better in four to six hours, said Song. The cases were all reported starting on May 11.

The Tianjin Institute for Drug Control said two batches of the drug tested positive in a pyrogen reaction test. Pyrogen reactions include chills, vomiting, high fever (up to 40 Celsius) and falling blood pressure. Severe reactions can be fatal.

Tianjin suspended the use of the drug on May 22. Cities and provinces including Beijing, Liaoning and Jilin also issued notices to hospitals, urging them to watch out for adverse reactions.

Initial investigation showed that the pharmaceutical company was not involved in illegal production, and the investigation would center on possible technical problems, said Wang.

Two problematic batches have already been recalled and now all the injections on the market would be recalled, said Wang.

"The risk is now under control," he said.

Since October, China has recalled herbal injections leading to adverse reactions including ciwujia, shuanghuanglian, yinzhihuang and qingkailing. A man was sentenced to eight years in jail for selling contaminated ciwujia injections that killed three people in southwestern Yunnan Province.

US FDA panel rejects Debiovision, Salix drug

* Drug designed to treat bleeding in the esophagus

* Panel voted 14-0 benefits not shown to outweigh risks

* Salix shares fall 2.4 percent (Adds panelist, company comments; updates shares)

SILVER SPRING, Md., - A U.S. advisory panel on Tuesday rejected a Debiovision Inc drug after members said the company lacked enough evidence to show it was effective for treating a dangerous type of bleeding in the esophagus.

The Food and Drug Administration advisory committee voted 14-0 that currently available data failed to show the benefits of the drug, Sanvar, outweighed risks.

Salix Pharmaceuticals (SLXP.O) holds U.S. marketing rights for the medicine. Salix shares fell 2.4 percent to close at $9.81 on Nasdaq.

Panel members shared concerns voiced by FDA reviewers that Debiovision's most recent study had limitations, including the lack of a control group. The company compared the results with patients who received a placebo in an earlier trial.

Some panelists felt "there was some small level of improvement" shown mainly in one study, "but it's been complicated by the other studies that we can't completely interpret," said Dr. Lin Chang, the committee's chairwoman and co-director of the UCLA Center for Neurovisceral Sciences and Women's Health.

Earlier, the committee voted 13-1 that Debiovision did not provide substantial evidence of the drug's effectiveness.

Panel members also said it was hard to tell if the drug contributed to serious problems including an abnormally slow heart beat and low blood platelets that were sometimes fatal. The panel was "not sure if they're due to the drug or (patients') chronic conditions," Chang said.

The FDA will consider the advice as it decides whether to clear sales of Sanvar, known generically as vapreotide. A ruling is due by July 1, although the agency has missed several drug review deadlines in recent months.

BMO Capital Markets analyst Robert Hazlett estimates peak sales of $50 million for Sanvar if it reaches the market.

Before the votes, Debiovision argued that Sanvar helped control esophageal bleeding that can develop from liver cirrhosis, which reduces blood flow to the liver and diverts the blood to tiny vessels lining the esophagus. The vessels can swell and burst, causing potentially fatal complications.

About 30,000 people in the United States will develop the condition, known as esophageal variceal bleeding, in 2009, the company said. Standard therapy involves putting a tube down the throat to seal the blood vessel, but it does not always work.

Debiovision told the panel its research showed adding intravenous Sanvar helped control bleeding, and the risks were similar whether patients were given the drug or a placebo.

Company officials also said doctors were using another drug, octreotide, that is not cleared for treating esophageal bleeding and that patients would be better served by an approved treatment. Octreotide is sold generically and by Novartis AG (NOVN.VX) (NVS.N) under the brand Sandostatin.

"Because of proven efficacy, lack of serious side effects and excellent tolerability, (Sanvar) has a favorable benefit/risk ratio," said Marco Petrella, Debiovision's director of clinical affairs and new product development.

Responding to an earlier application in 2004, the FDA said Sanvar was "approvable" but sought more evidence of effectiveness. The company said the FDA had approved the trial design that the agency reviewers and the panel criticized.

FDA reviewers said it was difficult to interpret the findings, however, because the standard treatment of esophageal bleeding had improved since the company's earlier research.

Debiovision is a unit of privately held Swiss pharmaceutical company Debiopharm.

Use of unapproved drugs violates sound process

It's likely news to most Canadians that the wide-spread use of antibiotics in livestock includes unapproved drugs, but it's been on Health Canada's radar for at least seven years. And as the keeper of public health, the federal department needs to crack down on farmers who allow such drugs to enter the food chain.

This week's issue of the Canadian Medical Association Journal highlights the controversial usage.

The article claims it's the result of a loophole in federal law that allows meat producers to import about $100-million worth of medications to Canada each year.

It is done with little oversight, under the "own-use" provision, meant for individuals to import up to a 90-day supply of drugs for personal consumption.

Unfortunately, it has come to be widely interpreted by farmers as a way to import drugs for their animals.

The loophole was first identified in 2002 by an advisory committee which recommended Health Canada then stop the imports immediately.

The drugs include unapproved and untested antibiotics, often given to healthy animals to speed their growth or prevent disease outbreaks. Farmers say they need to do this to remain competitive, even though the use of these antibiotics as growth promoters was banned in Europe three years ago because of health concerns.

Medical experts here also fear increases in antibiotic resistant bacterial infections in humans, and the subsequent development of superbacteria.

When exposed to low doses of drugs over a period of time, animals develop a bacteria that's antibiotic resistant.

That creates a potential breeding ground for a superbacteria. Humans are at risk for picking up the drug-resistant bacteria, either by consuming undercooked meat, or by having contact with farm wastes, manure or other environmental contact.

As complicated as the issue is, it can be pared down to one thing: the rules are there for a reason and should be followed. Health Canada should act on the concerns of the medical community and close this loophole immediately. All drugs imported for use in food production should first meet registration and licence requirements.

The CMAJ article is in response to a task force report, quietly posted to Health Canada's website in December. The recommendations by the committee, dominated by representatives of the livestock industry, called for Health Canada to keep the loophole in place for another two years for further study of the product.

Study is appropriate, of course, but this looks like an industry bid to buy time.

First, deal with the use of unapproved drugs.

Second, test them.

Finally, if the drugs check out, they should by all means be reinstated.

The process is sound: it should be allowed to work.

Transplant Rejection Drug OK'd

Gengraf (cyclosporine capsules, USP, [modified]) by Abbott Laboratories has received approval from the U.S. Food and Drug Administration.

Gengraf is an immunosuppressant indicated for the prevention of organ rejection in patients who have received kidney, liver or heart transplants. Gengraf is bioequivalent to and interchangeable with the leading cyclosporine capsule therapy, according to a company news release, but is priced lower.

Gengraf capsules were reported easy to swallow by a panel of 101 healthy volunteers. In that study, 94 of 101 participants preferred the aroma of Gengraf capsules to that of another brand of cyclosporine capsules, according to the company.

Cyclosporine is the leading immunosuppressive drug used to prevent graft rejection in liver, heart and kidney transplant patients, the company says. The market for cyclosporine in the United States accounts for $480 million in annual sales.

The bioequivalence of Gengraf and the other leading cyclosporine capsules was demonstrated in two well-controlled, randomized pharmacokinetic studies, according to Abbott Laboratories.