Regulatory Focus™ > News Articles > Marshals Seize Unapproved Drugs from Manufacturer After Purported INDA Violations

Marshals Seize Unapproved Drugs from Manufacturer After Purported INDA Violations

Posted 23 May 2012 | By Alexander Gaffney, RAC 

The US Marshals service, at the direction of the US Food and Drug Administration, moved on 22 May to seize stock of an unapproved drug product from pharmaceutical manufacturer Crescendo Therapeutics after the company allegedly continued to flaunt federal regulations.

FDA said Crescendo's HybriSil product, a methylprednisolone aceteate suspended in silicone gel, was being marketed as a prescription topical corticosteroid in various venues. The agency had inspected Crescendo in April 2011, when it initially said the company was violating marketing and branding regulations.

A subsequent January 2012 investigation by FDA found the company to still be in violation despite having submitted an Investigational New Drug Application (INDA) to FDA which prohibits the marketing of the investigational product for non-investigational purposes.

FDA further claims HybriSil is "misbranded because its labeling fails to carry adequate directions for use" -something noted in its initial investigation but not subsequently changed by Crescendo.

The agency also called on consumers to report any adverse events to FDA, noting "to date, the FDA has not received adverse event reports about HyriSil" from Crescendo.

The company's President, Eric Glader told Pharmalot that the seizure is the result of poor communication between the two parties.

"We had requested another meeting, but we didn't hear from [FDA]," explained Glader. "Instead, they sent us a letter this month to discontinue the product and the next day, Marshals showed up at our offices. But if that letter had come two or three months earlier, we would have removed product (from the market) then."

FDA's Associate Commissioner for Regulatory Affairs, Dara Corrigan, disagreed.

"This action was taken because Crescendo Therapeutics continued to sell unapproved new products," said Corrigan. "The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval."

Read more:

FDA - U.S. Marshals seize unapproved new drug from Crescendo Therapeutics LLC 

Pharmalot - What Regulations? The FDA Makes A Seizure

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