FDA Commissioner Robert Califf (Tom Williams/CQ Roll Call via AP Images)

FDA to im­port ver­sions of com­mon can­cer drug to al­le­vi­ate short­age

The FDA is hop­ing its lat­est so­lu­tion will stave off the con­tin­ued short­age of cis­platin, a key drug used in treat­ing sev­er­al types of can­cer.

Be­gin­ning to­mor­row, or­ders can be placed for cis­platin ship­ments from Chi­na-based Qilu Phar­ma­ceu­ti­cal Co., which worked in co­or­di­na­tion with the FDA and gener­ic drug­mak­er Apo­tex to try to help with the short­age.

FDA Com­mis­sion­er Robert Califf said on Fri­day that the agency be­gan the process to im­port cer­tain “for­eign-ap­proved ver­sions” of cis­platin from FDA-reg­is­tered fa­cil­i­ties. Ac­cord­ing to a doc­u­ment, Qilu has start­ed the “tem­po­rary im­por­ta­tion” of cis­platin in­to the US even though the in­jec­tion from Qilu is mar­ket­ed and man­u­fac­tured in Chi­na and is not ap­proved by the FDA.

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Associate

Alexandria Real Estate Equities

San Diego, CA, USA