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FDA Extends PDUFA Date for Megace ES to July 29, 2005


Summer Launch of Megace ES Still Anticipated

SPRING VALLEY, N.Y., April 18, 2005 -- Par Pharmaceutical Companies, Inc. 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(R) 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(R) 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, please visit www.parpharm.com.

Posted: April 2005

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