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