Medicis Pharmaceutical Corp. (MRX) revealed in an SEC filing that it has received FDA letter stating that, upon preliminary review of the company's Biologics License Application, or BLA, for the botulinum toxin type A, Reloxin, in aesthetics, the FDA has determined not to accept the BLA for filing because it is not sufficiently complete to permit a substantive review.
FDA cited reasons were that the application did not address how Medicis would fulfill its responsibilities as the manufacturer of the product and that the application included letters of authorization supporting a separate BLA submitted by Ipsen.
The FDA's letter only addressed administrative deficiencies in the application and did not reference any substantive deficiencies. The company continues to believe that its BLA is strong, and it plans to promptly work with the FDA and coordinate its activities with Ipsen to address these administrative issues.
While Medicis is uncertain of the impact at this time, the FDA's determination not to accept the company's BLA may result in delays in the FDA's substantive response to the BLA.
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