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FDA Grants Final Approval for Generic Proamatine
"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