Impax Laboratories, Inc. announced that the US Food and Drug Administration (FDA) has granted final approval of the company's Abbreviated New Drug Application (ANDA) for the generic version of Allegra-D (Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloride Extended-release) 60mg/120mg tablets. The company is preparing for product launch through global pharmaceuticals, Impax's generic division.
The FDA awarded Impax 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, LLC, markets Allegra-D for the treatment of the symptoms associated with seasonal allergic rhinitis. According to Wolters Kluwer Health, US branded and generic sales of Allegra-D 60mg/120mg tablets were approximately $214 million for the 12 months ended September 30, 2010.
Impax Laboratories, Inc. 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.