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FDA Grants Final Approval for Generic Proamatine

HAYWARD, Calif.--(BUSINESS WIRE)--May 28, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL) announced that the U.S. Food and Drug Administration (FDA) has granted final marketing approval to the Company's Abbreviated New Drug Application (ANDA) for its generic version of PROAMATINE(R), Midodrine Hydrochloride 2.5 and 5 mg Tablets. Shire Pharmaceuticals Group plc (Nasdaq:SHPGY) markets PROAMATINE for treatment of symptomatic orthostatic hypotension. According to NDCHealth, U.S. market sales of PROAMATINE 2.5 and 5 mg and the two other marketed generic versions were approximately $50 million in the twelve months ended March 31, 2004.

"This is our eighth ANDA approval this year," said Larry Hsu, Ph.D. IMPAX's President. "We are pleased to add Midodrine Hydrochloride Tablets to our growing portfolio of products. This product will be marketed by our Global Pharmaceuticals division."

IMPAX currently has 14 applications pending at the FDA, including five tentatively approved, which address approximately $5.2 billion in U.S. product sales for the twelve months ended March 31, 2004, based on NDCHealth data. Twelve of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

Source: Impax Laboratories

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