FDA ac­cepts Heron's painkiller re-sub­mis­sion; splits Blue­print Med­i­ci­nes' NDA for avapri­tinib

→ Near­ly six months ago, Heron was hand­ed an un­ex­pect­ed re­jec­tion by the FDA due to man­u­fac­tur­ing con­cerns for HTX-011 — a long-act­ing non-opi­oid painkiller for post-sur­gi­cal anal­ge­sia that would’ve ri­valed Paci­ra Phar­ma­ceu­ti­cals’ J&J-part­nered, long-act­ing post-op painkiller Ex­par­el. On Mon­day, the San Diego com­pa­ny said the US reg­u­la­tor had ac­cept­ed its re­sub­mit­ted mar­ket­ing ap­pli­ca­tion. The FDA is ex­pect­ed to make its de­ci­sion by March 26.

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