Mallinckrodt Statement on Extended-Release Methylphenidate Tablets
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. The company has submitted its request for a hearing to the U.S. Food and Drug Administration on the agency’s proposal to withdraw Mallinckrodt’s Abbreviated New Drug Application for the drugs and is preparing the related documentation that is required. The company intends to continue vigorously defending the safety and efficacy of its product.
November 16, 2016