Was Apokyn Safety Update A Missed Opportunity For Supernus To Hold Off Generic Refill Cartridge?
US FDA told the company to add a warning to the label in late January, about a month before the generic refill cartridge was approved.
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Agency refutes Supernus’ defense that Sage’s generic drug cartridges are ‘free-riding’ on the supply of the injector pen for its branded product. Company’s alleged exclusionary contract with pen distributor and pressure on specialty pharmacies not to provide the generic involve important antitrust issues, FTC tells court.
PhRMA expresses concerns the provision would reveal trade secrets, but since the draft bill already has support from the Republican committee leadership, the brand industry may find it a challenge to get the language removed.
Reports of bent needles and injector failures also raise questions about the FDA’s complex product approval process.