Noven Receives FDA Warning Letter for Daytrana Patch

The FDA issued a warning letter for the Daytrana patch pertaining to consumers' problems in removing the release liner, but not the safety of medication.

Friday January 11th - 10:41am

Noven Pharmaceuticals received a warning letter, which stemmed from a July inspection of their production facilities, regarding the Daytrana patch.

The letter, which was released January 10, noted that some patients had difficulty removing the release liner from the Daytrana patch. The letter did not restrict production or shipment of the patch, but asked for further analysis of possible deficiencies in the product and its backing. It also stated that failure to address the issues may lead to regulatory action.

Noven submitted a response to the FDA, and made a statement saying they are working to "fully resolve the issues."

FDA is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for Attention Deficit Hyperactivity Disorder (ADHD). FDA added a new warning to the drug label to describe this skin condition, which is known as chemical leukoderma. See the FDA Drug Safety Communication for more information.

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