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FDA Approves Generic Version of Sinemet CR
"As only the second generic approval, this illustrates our strategy of applying our drug delivery technology to compounds with limited competition," said Larry Hsu, Ph.D., IMPAX's President. "We are also pleased to note that this is our sixth approval this year."
IMPAX currently has 16 applications pending at the FDA, including five tentatively approved, which address approximately $5.3 billion in U.S. market sales for the 12 months ended February 29, 2004 as reported in NDCHealth data. Twelve of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.
Source: IMPAX Laboratories, Inc.