The seizure, which took place under a warrant issued by the U.S. District Court for the Southern District of California, follows two FDA inspections of Crescendo.
During the first inspection in April 2011, the FDA found that Crescendo was marketing HybriSil as a prescription topical corticosteroid, intended to treat scars and skin disorders. FDA warned the company in November 2011 that HybriSil was an unapproved new drug product, which could not be marketed without approval by the FDA based on data showing that the product is safe and effective for its intended use. On January 3, 2012, Crescendo submitted an Investigational New Drug Application for HybriSil that permitted the limited distribution of the product for investigational use only. However, a subsequent FDA inspection conducted later that month confirmed that Crescendo continues to distribute HybriSil for non-investigational purposes.
The FDA also determined that HybriSil is misbranded because its labeling fails to carry adequate directions for use. In a follow-up January 2012 inspection, the FDA found that Crescendo was still distributing HybriSil, despite the warnings.
“This action was taken because Crescendo Therapeutics continued to sell unapproved new products,” said Dara A. Corrigan, the FDA’s associate commissioner for regulatory affairs. “The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval.”
There are many other topical corticosteroids approved by the FDA for treating skin disorders that are available to consumers.
“The FDA is committed to taking enforcement action against companies that circumvent the drug approval process,” said Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research. “Consumers need to be confident that the drugs and medical products they use have been reviewed by FDA and are safe and effective.”
To date, the FDA has not received adverse event reports about HybriSil. Consumers and health care professionals should notify the FDA of any problems associated with the product. Reports may be made to MedWatch, the FDA's voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
