The complete response letter Tesaro Inc. received from US FDA this week likely won’t create major delays for approval of intravenous rolapitant, but it does continue a recent trend of increasing CRLs pertaining to chemistry, manufacturing and controls-related issues.
US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing
Tesaro’s IV formulation of Varubi draws letter keeping with last year’s emerging trend of manufacturing-related CRLs, in this case agency concerns about CMC data related to comparability of drug produced by two different contractors; issue seems unlikely to significantly delay approval of the new version of CINV drug, however.
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