Xanodyne Pharmaceuticals, Inc. To Voluntarily Withdraw Darvon® and Darvocet-N® Products

Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon^®, Darvon-N^®, and Darvocet-N^®products from the U.S. market in consultation with the U.S. Food and Drug Administration(FDA).

This withdrawal is part of a market-wide withdrawal applying to all propoxyphene-containing products, affecting branded and generic pharmaceutical companies and a number of products on the market.

Propoxyphene is a mild opiate used for the treatment of mild-to-moderate pain and has been on the U.S. market for the last 50 years.

On January 30, 2009, a meeting of the FDA Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee was convened to review the efficacy and safety of propoxyphene-containing products. Following that meeting, Xanodyne agreed to work together with the FDA, and took a number of steps including developing a patient medication guide, strengthening several of the warnings in the product labeling, and conducting a clinical study to assess the maximum tolerated dose and effects of propoxyphene on cardiac conduction.

Xanodyne announces new president, equity financing

Xanodyne Pharmaceuticals Inc. said Thursday it has hired Michael Valentino as its president and CEO and completed $38 million in equity financing.

Valentino was most recently president and CEO of New Jersey-based Adams Respiratory Therapeutics, which was acquired in 2008 by British firm Reckett Benckiser. He has held management positions with major drug companies, including Alpharma, Novartis, Pharmacia/Upjohn and Warner Lambert. Valentino replaces William Nuerge, who was named CEO of Xanodyne in 2004 and left the company in 2007.

Xanodyne’s priorities will be to bring to market its Zipsor acute pain treatment, and XP12B, a drug in development for heavy menstrual bleeding, Valentino said in a news release.

The company also said it completed $38 million in equity financing, led by MPM Capital, a Boston-based health care equity firm. Other investors in the company include AIG Investments’ sponsored funds, Aisling Capital, Blue Chip Venture Co., Essex Woodlands, HealthCare Ventures LLC and Union Springs.

“Mike brings major pharmaceutical and commercial experience to the team while the financing brings critical resources needed for the launches,” said Rolf Classon, board chairman, in the release.

Xanodyne, based in Newport, is a specialty pharmaceutical company focused on treatments for women’s health care and pain management.

Caraco Pharmaceutical Laboratories, Ltd. Markets Generic Roxicodone(R) Tablets

DETROIT,- Caraco Pharmaceutical Laboratories, Ltd. (NYSE Amex: CPD) has recently launched oxycodone hydrochloride tablets on behalf of Sun Pharmaceutical Industries Inc., a subsidiary of Sun Pharmaceutical Industries Ltd. (Sun Pharma), following Sun Pharma's recently received approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for generic Roxicodone(R) tablets.

Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. These generic versions of oxycodone 5 mg, 15 mg, and 30 mg tablets are therapeutically equivalent to Roxicodone(R) tablets from Xanodyne Pharmaceuticals Inc. According to IMS Data, these strengths of oxycodone tablets had US sales of approximately $160 million for the calendar year of 2008.

Daniel H. Movens, Caraco's Chief Executive Officer, said, "We are pleased to add this product to our portfolio and help address the current shortage in the marketplace by launching oxycodone tablets. We continue to focus on working towards expanding our product offerings both as a marketing partner and through our own development pipeline of products as quickly and effectively as possible."

Roxicodone(R) is a registered trademark of Xanodyne Pharmaceuticals Inc.

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures, markets and distributes generic and private-label pharmaceuticals to the nation's largest wholesalers, distributors, drugstore chains and managed care providers.

Safe Harbor: This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include, but are not limited to: information of a preliminary nature that may be subject to adjustment, potentially not obtaining or delay in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, dependence on few products generating majority of sales, product liability claims for which the Company may be inadequately insured, and other risks identified in this report and from time to time in our periodic reports and registration statements. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.