IMPAX Receives Final FDA Approval for Generic Version of Claritin-D 24-Hour

Law360, New York (March 5, 2004, 12:00 AM EST) -- The U.S. Food and Drug Administration has granted final approval to Impax Laboratories' Abbreviated New Drug Application (ANDA) for a generic version of Schering-Plough’s Claritin(R)-D 24-Hour Extended Release Tablets, Impax said.

The company said it filed the ANDA with a Paragraph IV certification under the Hatch-Waxman Amendments, indicating it is challenging the validity of Schering-Plough’s patent for the drug.

Generics drug applicants must include with ANDAs a statement addressing the generic drug's relationship to each Orange Book-listed patent of the original branded drug. Paragraph IV certifications...
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