Processing Magazine

Noven Pharma Gets FDA Warning Letter

January 10, 2008
The Associated Press reported that Noven Pharmaceuticals Inc., which makes skin patches for drug delivery, said recently it received a warning letter from the Food and Drug Administration related to a mid-2007 Miami facility inspection.

As previously disclosed, an inspection in early July noted difficulties experienced by some patients in removing the release liner, or backing material, of the Daytrana patch product used to treat Attention Deficit Hyperactivity Disorder (ADHD).

Noven said it submitted a response to the FDA''s observations in July.

The warning letter does not restrict production or shipment of Daytrana, but requests additional information and analysis related to the cited deficiencies of the product. The letter instructs Noven to take prompt action to address the FDA''s concerns, and states that failure to do so may result in further regulatory action.