Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets

The Food and Drug Administration (FDA or the Agency) is announcing a formal evidentiary public hearing on the proposal to withdraw approval of the abbreviated new drug application (ANDA) 091695, submitted by Kremers Urban Pharmaceuticals, Inc. (Kremers) for methylphenidate hydrochloride extended-release tablets. On October 18, 2016, the Director of FDA's Center for Drug Evaluation and Research (CDER) published a notice of opportunity for hearing on a proposal to withdraw approval of ANDA 091695. Kremers submitted a timely request for hearing on that proposal. This notice of hearing provides factual and legal information concerning CDER's proposal to withdraw approval of ANDA 091695 and identifies the factual issues that will be the subject of the evidentiary hearing.