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 for the gel formulation in 1991 and for the cream formulations in 1992. The ANDA submissions were premised on the theory - worked out with the FDA at the time - that retinoic acid is the same as the product in Retin-A, and the company's TopiCare Delivery Compounds are sufficiently inert that the formulation shouldn't be considered a new drug, said Edgar Luce, vice president of finance.


The agency then