Mallinckrodt requested a 90-day extension of the deadline for submitting documentation supporting the necessity of a hearing on the U.S. Food and Drug Administration's (FDA's) proposal to withdraw the company's Abbreviated New Drug Application for its Extended-Release Methylphenidate Tablets.
The agency has granted that request, with a new deadline of March 19, 2017.
The company concurrently submitted its request for the hearing to the FDA as well, and is preparing the supporting documentation for the March submission. It remains Mallinckrodt's position that its generic methylphenidate ER products are a safe and effective treatment option for patients who suffer from attention-deficit and hyperactivity disorder.
November 23, 2016