Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics. The medication, HybriSil (methylprednisolone acetate 1% percent in silicone gel) was marketed for the treatment of scars and skin disorders, an indication for which it did not have FDA approval.
The seizure follows two FDA inspections of Crescendo Therapeutics. After an April 2011 inspection, FDA cited the company in a Warning Letter for failing to have written procedures in place for the surveillance, receipt, evaluation, and reporting to FDA of adverse drug experiences. FDA also cited the company for violating the Food, Drug, and Cosmetic Act by distributing an unapproved new drug and ordered Crescendo Therapeutics to stop distributing the product.
According to the FDA press release, Crescendo Therapeutics submitted an investigational new drug application for HybriSil, but a January 2011 inspection by the agency found that that Crescendo continued to distribute HybriSil for non-investigational purposes. In the release, Dara A. Corrigan, FDA’s associate commissioner for regulatory affairs, says, “This action was taken because Crescendo Therapeutics continued to sell unapproved new products. The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval.”