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news.Impax Laboratories has received final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for the generic version of Allegra-D (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets.
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Impax’s generic division Global Pharmaceuticals is expected to launch the product.
Impax claimed that the FDA awarded the company 180 days of generic drug exclusivity as it was the first ANDA applicant to submit a substantially complete ANDA with paragraph IV certifications to the 6,399,632, 7,135,571 and 7,138,524 patents, and was one of the first ANDA applicants to submit a substantially complete ANDA with paragraph IV certifications to the 7,662,835 and 7,666,881 patents.
Sanofi Aventis US markets Allegra-D for the treatment of the symptoms associated with seasonal allergic rhinitis.
Impax Laboratories 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.
Impax markets its branded products through the Impax Pharmaceuticals division.