FDA Approves First Generic Through FDARA-Created Pathway

August 08, 2018
FDA announced Wednesday (Aug. 8) the first generic drug, Apotex's oral potassium solution, has been approved under the “competitive generic therapy” pathway created by FDA Reauthorization Act in 2017. One attorney closely following the pathway says he's anticipating the release of the drug's approval letter, which may give more details on how FDA will interpret a provision of the law that could force drug makers to give up the pathway's lucrative exclusivity award. Sponsors also are entitled to 180 days...

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