FDA re­jects Tesaro’s IV ver­sion of ro­lap­i­tant, cit­ing man­u­fac­tur­ing is­sues

Tesaro’s plans for build­ing up sales of Varu­bi — or ro­lap­i­tant — through a new in­tra­venous for­mu­la­tion of the drug will have to wait. The FDA shot down the biotech’s mar­ket­ing ap­pli­ca­tion, which the biotech says is sole­ly dur­ing to some out­stand­ing man­u­fac­tur­ing is­sues.

The pill ver­sion of the drug — used to treat chemo in­duced nau­sea and vom­it­ing — was OK’d back in 2015, trig­ger­ing a block­buster pro­jec­tion from the com­pa­ny. An­a­lysts, though, have been less than im­pressed with the roll­out, with Leerink pulling back its fore­cast on sales.

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