New Anti-Nausea Suppository Introduced
Paddock Laboratories has introduced Compro (prochlorperazine) suppositories in a 25 mg form for the treatment of nausea and vomiting in adults.
Compro is contraindicated in patients with known hypersensitivity to phenothiazines, in comatose patients and in the presence of large amounts of central nervous system depressants, according to a company news release.
Compro is available in boxes of 12. Paddock Laboratories offers a significant number of prescription suppositories.
'Abortion Drug' Cleared After Lengthy Squabbles
After many years of fighting, the FDA has cleared RU-486 (mifepristone) for use in abortions. The drug will be sold as Mifeprex by Danco Laboratories.
The major restriction placed on the drug by the FDA is that it will not be available from pharmacies, even with a prescription. Instead, it will be distributed directly to offices or clinics, and clinicians will have to sign a statement certifying that they have met specific requirements before they can place an order.
Mifeprex is approved for use for up to seven weeks following the beginning of a woman's last menstrual period and can be prescribed as soon as pregnancy is confirmed. The total treatment requires three visits to the provider and requires a woman to also take the contraction-inducing drug misoprostol. The drug combination is 92% to 95% effective at ending pregnancy, according to Danco.
The FDA had considered much stronger restrictions on Mifeprex. A bill that would impose further restrictions on the drug is now in the U.S. Senate.
FDA Clears New HIV Drug Kaletra
The FDA has cleared Kaletra (lopinavir/ritonavir) for marketing. Kaletra, by Abbott Laboratories, combines the protease inhibitor lopinavir with a small dose of the protease inhibitor ritonavir, which is believed to slow the body's metabolism of lopinavir and enhance its ability to fight HIV.
The FDA granted accelerated approval to Abbott to market Kaletra, formerly known as ABT-378/r, to adults and children with HIV. It is the first protease inhibitor to be approved for use in children as young as 6 months.
Kaletra will be available in capsules and as a liquid, and dosing is relatively simple: three pills taken twice a day. Kaletra will be marketed while clinical trials continue. Abbott expects the FDA to grant full approval once it reviews safety and efficacy data from the completed clinical trials.
Fosamax Approved for Use in Men, Too
The FDA has approved Merck & Co.'s osteoporosis drug Fosamax (alendronate) for use in men to increase bone mass, making it the first medication indicated for treating men with osteoporosis.
About 2 million men in the United States already suffer from osteoporosis, according to Merck. The number of men with the disease is expected to increase by about 20% in the next 15 years.
Fosamax should be used with caution in patients with certain stomach or digestive problems. It should not be used in patients with disorders of the esophagus that delay emptying or in patients who are unable to stand or sit upright for at least 30 minutes. Fosamax also should not be used in patients with severe kidney disease or low levels of calcium, or in pregnant or breastfeeding patients.
Drug Now Available for A-Fib/Atrial Flutter
Betapace AF (sotalol) is now available from Berlex Laboratories for treating highly symptomatic atrial fibrillation/atrial flutter. It is the first and only sotalol indicated for the treatment of this problem, according to a company news release.
Betapace AF is not therapeutically equivalent to Betapace or generic sotalol, according to the company, because of significant differences in labeling. Patients should be advised to read the patient package insert and reread it each time therapy is renewed.
Notables
Wyeth-Ayerst Laboratories has sent an update to health care providers regarding the Norplant System (levonorgestrel implants). Women who have received Norplant from lots distributed on or after Oct. 20, 1999, are advised to use a backup barrier or nonhormonal contraceptive, because the effectiveness of these lots cannot be guaranteed. ... The FDA has approved a new indication for Levaquin (levofloxacin) Tablets/Injection by Ortho-McNeil to treat complicated skin and skin structure infections at a dose of 750 mg daily. ... An FDA advisory panel recommends that U.S. officials should restrict the use of acne drug Accutane (isotretinoin) by Hoffman-La Roche to reduce the number of women taking it who risk birth defects by becoming pregnant.
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