US Marshals Seize Unapproved Drug From Crescendo Therapeutics
Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics.
Federal marshals seized an unapproved topical corticosteroid medication from California-based Crescendo Therapeutics. The medication, HybriSil (methylprednisolone acetate 1% percent in silicone gel) was marketed for the treatment of scars and skin disorders, an indication for which it did not have FDA approval.
The seizure follows two FDA inspections of Crescendo Therapeutics. After an April 2011 inspection, FDA cited the company in a Warning Letter for failing to have written procedures in place for the surveillance, receipt, evaluation, and reporting to FDA of adverse drug experiences. FDA also cited the company for violating the Food, Drug, and Cosmetic Act by distributing an unapproved new drug and ordered Crescendo Therapeutics to stop distributing the product.
According to the FDA press release, Crescendo Therapeutics submitted an investigational new drug application for HybriSil, but a January 2011 inspection by the agency found that that Crescendo continued to distribute HybriSil for non-investigational purposes. In the release, Dara A. Corrigan, FDA’s associate commissioner for regulatory affairs, says, “This action was taken because Crescendo Therapeutics continued to sell unapproved new products. The FDA continues to be committed to protecting consumers against new drug products marketed without FDA approval.”
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
