Noven Pharmaceuticals, which manufactures Shire’s attention deficit hyperactivity disorder patch Daytrana said it received a warning letter from the FDA related to a prior on-site inspection of its manufacturing facility in Miami.
In the warning letter, the FDA requests additional information and analysis related to deficiencies associated with the peel force specifications for removal the Daytrana system’s release liner.
The requests that Noven to take prompt action to address the FDA’s concerns, stating failure to do so may result in further regulatory action.
Noven said in a statement it is ‘working very closely’ with to ‘promptly’ respond to the FDA letter, and is committed to working collaboratively with regulators to fully resolve the issues.
