Spring Valley, New York, April 18, 2005 — Par Pharmaceutical Companies, Inc. (NYSE:PRX)
today announced that it was notified by the U.S. Food and Drug Administration (FDA) on April 15, 2005, that the FDA has extended the original 10-month Prescription Drug User Fee Act (PDUFA) goal date for the completion of its review of Par's New Drug Application (NDA) for Megace® ES (megestrol acetate) oral suspension. The original user fee goal date for the Megace® ES NDA was April 29, 2005.
The extension results from Par's recent submission, at the FDA's request, of existing supplemental data on Megace® ES. In accordance with FDA regulations, the new PDUFA goal date has been extended three months to July 29, 2005. Following discussions with the FDA, Par believes that the Agency may complete its review of Megace® ES prior to the new goal date.
"Based upon our discussions with the FDA, we continue to look forward to a summer launch of Megace® ES," said Scott Tarriff, president and chief executive officer.
Megace® ES is an advanced formulation of megestrol acetate. This advanced formulation utilizes NanoCrystal® Dispersion technology to improve the bioavailablity of the drug, compared to currently available formulations of the product. If cleared for marketing, Megace® ES is expected to be indicated for the treatment of anorexia, cachexia, or any unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS). NanoCrystal® Dispersion technology is a registered trademark of Elan Pharmaceutical International, Ltd. Par licensed the Megace® brand name from Bristol-Myers Squibb Company.
Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic pharmaceuticals through its principal subsidiary, Par Pharmaceutical, Inc. The company is also developing an additional line of branded pharmaceutical products for specialty markets and expects to introduce the first of these, Megace® ES, in 2005. Par currently manufactures, markets or licenses more than 85 prescription drugs. For press release and other company information, visit http://www.parpharm.com.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. To the extent any statements made in this news release contain information that is not historical, these statements are essentially forward-looking and are subject to risks and uncertainties, including the difficulty of predicting FDA filings and approvals, acceptance and demand for new pharmaceutical products, the impact of competitive products and pricing, new product development and launch, reliance on key strategic alliances, uncertainty of patent litigation filed against us, availability of raw materials, the regulatory environment, fluctuations in operating results and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, such as the Company's Form 10-K, Form 10-Q, and Form 8-K reports.
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