Martine Rothblatt (AP Photo/Jack Plunkett)

FDA re­jects Unit­ed's po­ten­tial PAH drug due to a man­u­fac­tur­ing is­sue

Unit­ed Ther­a­peu­tics said Mon­day that it re­ceived a com­plete re­sponse let­ter for its po­ten­tial pul­monary ar­te­r­i­al hy­per­ten­sion drug Ty­va­so DPI, due to an is­sue with a third-par­ty fa­cil­i­ty that per­forms drug sub­stance test­ing. The com­pa­ny said it ex­pects an ap­proval will come by next sum­mer.

The in­spec­tion is­sue ap­pears to be the on­ly prob­lem the FDA took no­tice of, ac­cord­ing to Unit­ed. There were no is­sues with pack­ag­ing, man­u­fac­tur­ing or test­ing Ty­va­so DPI at the MannKind Cor­po­ra­tion fa­cil­i­ty, the com­pa­ny said.

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