Impax Laboratories, Inc., a technology based specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved the Company's Abbreviated New Drug Application (ANDA) for a generic version of Claritin-D 12-Hour (Loratadine/Pseudoephedrine sulfate, 5mg/120mg) Extended Release Tablets. FDA approved a switch in Claritin-D 12-Hour's status from a prescription drug to an over-the-counter (OTC) drug for the relief of symptoms of seasonal allergic rhinitis (hay fever) on December 9, 2002.
Under the terms of a non-exclusive Licensing, Contract Manufacturing and Supply Agreement with Schering-Plough Corporation and a semi-exclusive Development, License and Supply Agreement with Wyeth acting through its Wyeth Consumer Healthcare Division, Impax will supply both companies for the OTC market. Shipment of the product is expected to commence shortly.
"As we were the first company to file an ANDA with a Paragraph IV certification," said Larry Hsu, Ph.D. President of Impax Laboratories, "we have been awarded 180 days of marketing exclusivity commencing with the first commercial marketing."
After this approval, Impax has 19 applications pending at the FDA, including four tentatively approved, that address approximately $5.8 billion in U.S. branded product sales for the 12 months ended September 30, 2002. Fourteen of Impax's filings were made under Paragraph IV of the Hatch-Waxman Amendments.