US FDA’s First Complete Response Letter Of 2017 Involves … Manufacturing

13 Jan 2017

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.

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.

The Waltham, MA-based biotech revealed the complete response Jan. 11, which was the FDA action date for its NDA for...