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The US Food and Drug Administration (FDA) issued Form 483 to Noven Pharmaceuticals. Form 483 is a list of observations made during the inspection that is communicated at the conclusion of the inspection. Noven is a fully integrated specialty pharmaceutical company with industry leading transdermal expertise.
The FDA wrote up Noven Pharmaceuticals for lapses in batch reviews and testing, stability and process controls, and complaints handling. The Form 483 notes that cold flow testing and testing of adhesive transfer were lacking for Noven’s Minivelle, and Daytrana transdermal patches.
Daytrana is a skin patch that contains methylphenidate, a central nervous system stimulant. Methylphenidate affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Daytrana skin patches are used to treat attention deficit hyperactivity disorder (ADHD).
The Form 483 issued to Noven by the FDA carried 13 counts. The Daytrana patch is designed to feed medication in a controlled fashion to the patient through the skin. However, there have been reports of Daytrana skin color loss and other Daytrana side effects associated with the product. While rare, the loss of pigmentation can be permanent.
In addition to that the Noven manufacturing facility located in Miami, Florida, was subject to a series of inspections from June 22 through July 10 of this year. Inspectors found various deficiencies. To wit, the accuracy, sensitivity, specificity and reproducibility of test methods were not established and documented. Amongst other issues, the FDA noted that Noven initiated a nationwide recall, on July 27, of no fewer than 125,250 Daytrana skin patches due to an adhesive peel force that was out of specification.