IMPAX Laboratories, Inc
. has announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company's Abbreviated New Drug Application (ANDA) for Carbidopa/Levodopa Extended Release Tablets, its generic version of Sinemet(R) CR tablets. Bristol-Myers Squibb markets Merck & Co.'s Sinemet CR exclusively in the U.S. for the treatment of Parkinsonism. According to NDCHealth, U.S. prescription sales of Sinemet CR and the one currently marketed generic equivalent were $126 million in the 12 months ended February 29, 2004. IMPAX's Global Pharmaceuticals division will begin marketing the product shortly.
"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.