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FDA Approves Generic Mestinon, Treatment for Myasthenia Gravis

HAYWARD, Calif.--(BUSINESS WIRE)--April 28, 2003--IMPAX Laboratories, Inc. (Nasdaq:IPXL - News) today announced that the U.S. Food and Drug Administration (FDA) has granted approval to the Company's Abbreviated New Drug Application (ANDA) for a generic version of Mestinon® (Pyridostigmine Bromide) 60 mg. tablets. ICN Pharmaceuticals, Inc. markets Mestinon® for the symptomatic treatment of myasthenia gravis. Myasthenia gravis is a neuromuscular disorder primarily characterized by muscle weakness and rapid muscle fatigue. According to IMS Health, U.S. sales of Mestinon® were $19 million for the 12 months ended December 31, 2002.

IMPAX has 18 applications pending at the FDA, including three tentatively approved, that address more than $5.8 billion in U.S. branded product sales for the 12 months ended December 31, 2002. Thirteen of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

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