FDA issues warning letter to Daytrana manufacturer

Share this article:

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.

Share this article:

Email Newsletters

More in News

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.