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:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders


Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 

MM&M EBOOK: PATIENT ACCESS

Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...