HAYWARD, Calif.--(BUSINESS WIRE)--March 23, 2004--IMPAX Laboratories, Inc. (Nasdaq:IPXL - News) 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 Declomycin® (Demeclocycline Hydrochloride) 150 and 300 mg. Tablets. ESP Pharma markets Declomycin for the treatment of various infections. According to NDCHealth, U.S. sales of Declomycin were approximately $28 million for the 12 months ended December 31, 2003. IMPAX's Global Pharmaceuticals division will begin marketing the product immediately.
"This, our fifth ANDA approval and the third final approval this year, once again demonstrates the depth of both our R&D and Regulatory teams," said Larry Hsu, Ph.D. IMPAX's President. "We are pleased to add Demeclocycline Hydrochloride Tablets to our growing portfolio of products. As the first generic version of Declomycin approved by the FDA, this product should offer both patients and payors a cost effective alternative to the brand."
Source: Impax Laboratories