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I Heard That Hybrisil Was Given a Warning Letter and Being Taken off the Market?

  • laurasandiego
  • san diego, CA
  • 2 years ago

I Heard That Hybrisil Was Given a Warning Letter and Being Taken off the Market?

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HybriSil indeed has encountered FDA enforcement, according to the blog/news site Pharmalot

 

For months, Crescendo Therapeutics appears to have been thumbing its corporate nose at the FDA. Last November, the agency warned the little company for failing to maintain a system for collecting adverse event reports for its HybriSil topical treatment for scars. Crescendo offered a novel explanation – side effect reports simply had not been received (back story). Moreover, the FDA upbraided Crescendo for marketing HybriSil in the first place – the product, you see, was never approved.


This past January, however, Crescendo attempted to make amends and submitted an Investigational New Drug Application that permitted limited distribution – specifically, for investigational use only. But after another FDA inspection, the agency noted that HybrSil was still being distributed for other purposes. The product web site, for instance, continued to solicit physicians to stock the treatment, which is a corticosteroid (the site was taken down last night). Meanwhile, the labeling failed to carry adequate directions for use.....

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