Compounding Draft Guidance May End Par's Suit Against US FDA
Par says FDA shouldn't have authorized a compounded version of Vasostrict, but parties have asked court to wait until March, when a guidance is expected that may resolve the company's concerns.
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In a clean sweep for Eagle Pharmaceuticals, following its recent approval for the first generic version of Par’s Vasostrict, the ANDA sponsor has seen defeated a Par citizen petition and dodged injunctive action launched by the Endo subsidiary.
FDA Slams Citizen Petition: Harsh Language, FTC Referral Suggest Tougher Stance On ANDA Delay Tactics
While the FTC referral is not unique, this seems the first time US FDA has cited intent to delay generic approval as a ground for denying a citizen petition. With Califf's confirmation hearing suggesting some bipartisan consensus on the issue, FDA might soon find itself with new powers.
Company argues there is a clinical need for its ready-to-use, preservative-free compounded formulation of vasopressin but agency says Vasostrict is available in a dose without the preservative.