U.S. Marshals Seize Unapproved New Drug From Crescendo Therapeutics LLC

California firm previously warned not to market HybriSil topical corticosteroid

U.S. Marshals, acting at the request of the Food and Drug Administration, have seized HybriSil (methylprednisolone acetate 1% percent in silicone gel), an unapproved new drug marketed by Crescendo Therapeutics, LLC, of Vista, Calif.

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.htm1.

For more information:

Crescendo Therapeutics Warning Letter2 Marketed Unapproved Drugs

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Sarah Clark-Lynn 301-796-9110, sarah.clark-lynn@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

Posted: May 2012


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