At the request of the Food and Drug Administration, U.S. Marshals seized an unapproved topical corticosteroid gel marketed by Crescendo Therapeutics.
The move was not entirely unexpected, as the FDA warned Crescendo in November 2011 that marketing of the drug, HybriSil (methylprednisolone acetate 1% in silicone gel), was illegal because it had never been approved and was being misbranded.
After the November warning, Crescendo responded to the FDA that it intended to file an investigational new drug (IND) application, according to the company president and CEO, Eric Glader. It made that filing in January 2012.
However, the FDA made a return inspection of Crescendo in late January and determined the company still was distributing the product for noninvestigational purposes. In early May, the FDA ordered Crescendo to discontinue manufacturing, and the company agreed.
The seizure was undertaken to ensure no more product would reach the market. The FDA said it has not received any reports of adverse reactions associated with HybriSil.
Mr. Glader said in an interview with Skin & Allergy News that Crescendo has begun clinical trials and intends to work with the agency to secure approval of a prescription HybriSil, and eventually, an over-the-counter version.