ScPhar­ma's stock droops on 'd­e­fi­cien­cies' as FDA toss­es back heart fail­ure drug ap­pli­ca­tion

It’s vague news from the FDA Thurs­day morn­ing that halt­ed — then tanked — the stock of scPhar­ma­ceu­ti­cals, a Burling­ton, MA-based com­pa­ny await­ing a reg­u­la­to­ry de­ci­sion on its heart fail­ure drug furosemide.

The com­pa­ny’s PDU­FA date was set for June 23, but re­ceived an ear­ly let­ter from reg­u­la­tors that the agency had “iden­ti­fied de­fi­cien­cies” with the com­pa­ny’s drug-de­vice com­bo that “pre­clude dis­cus­sion of la­bel­ing and post­mar­ket­ing re­quire­ments/com­mit­ments at this time.”

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