FDA Approval Track Record Since Advent of Complete Response Letters

It has been four months since FDA's CDER began issuing Complete Response Letters in place of Approvable or non-approval letters.  Looking back to August to get an idea of where we are in terms of the approval of new molecular entities it is apparent that the pipeline has not been robust, though the number of complete response letters has been comparatively high.

Approvals v CRLs
The approvals included:

  • Cleviprex – The Medicines Company
  • Xenazine – Biovail Americas 
  • Iobenguane Sulfate – GE Healthcare  
  • Rapaflo – Watson Labs 
  • Vimpat – Schwartz Biosciences 
  • Banzel – Eisai 
  • Promacta – GSK 
  • Tapentadol – J&J  

The Complete Response Letters include two biologics, both monoclonal antibodies and one NDA that had a priority review.   Also one drug received an approval and a complete response for different indications.  

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One Response to FDA Approval Track Record Since Advent of Complete Response Letters

  1. J-Mac says:

    Hi Mark
    Question:
    with respect to the drug which received an approval and a complete response for different indications, was it based on one or two NDAs?
    Thanks in advance
    p.s. great blog many thanks