The US Food and Drug Administration (FDA) has granted final approval to IMPAX Laboratories' Abbreviated New Drug Application for a generic version of Wellbutrin SR (Bupropion Hydrochloride) 200mg Tablets. The FDA also awarded the Company first-to-file status and 180-day market exclusivity for this product.

GlaxoSmithKline markets Wellbutrin SR for the treatment of depression. US sales of Wellbutrin SR 200mg Tablets were approximately $212 million in the 12 months ended October 31, 2004, according to NDCHealth. IMPAX's Global Pharmaceuticals division will begin marketing this product in the near future.

"We are happy to have received this approval, our second with first-to-file exclusivity," Larry Hsu, IMPAX's president said adding, "This, our eleventh approval in 2004, continues to validate our ability to develop products that have limited market competition."

IMPAX currently has 14 applications pending at the FDA, including four tentatively approved, which address approximately $5 billion in US branded product sales for the 12 months ended October 31, 2004. Nine of these filings were made under Paragraph IV of the Hatch-Waxman Amendments.

IMPAX Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products.