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The latest non-approvable victim

The latest non-approvable victim

The user fee system has struck again, with the FDA issuing not approvable letters to Penederm Inc. for its NDAs for retinoic acid gel and three cream formulations for the treatment of acne. The agency raised manufacturing and clinical issues in its communication to the Foster City, Calif., company.

The products, which are approved in Canada, have a convoluted history at the FDA. ANDAs were submitted

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