Federal Register #FDA-2016-N-3120

FDA Public Hearing on Withdrawal of Approval for Kremers Urban Pharmaceuticals' Generic Extended-Release Methylphenidate Tablets (ANDA 091695)

This FDA public hearing addresses the proposed withdrawal of approval for Kremers Urban Pharmaceuticals' generic extended-release methylphenidate tablets (ANDA 091695): - The hearing is a regulatory event, not a procurement or award opportunity. - Focus is on whether Kremers' generic product is bioequivalent to CONCERTA (Janssen Pharmaceuticals), especially for maintaining therapeutic effect over 12 hours. - FDA's Center for Drug Evaluation and Research (CDER) raised concerns about insufficient effectiveness in the latter part of the dosing period based on post-approval reports. - Kremers Urban Pharmaceuticals (now owned by Lannett Company, Inc.) must provide scientific evidence to prove bioequivalence. - The hearing involves Kremers Urban Pharmaceuticals, Janssen Pharmaceuticals, and the FDA; no products or services are being purchased or solicited. - Also noted: The NIH's National Heart, Lung, and Blood Institute is offering licensing for novel spironolactone analogues as anti-inflammatory therapeutics, but this is unrelated to the FDA hearing.

Description

The Food and Drug Administration (FDA) 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. for methylphenidate hydrochloride extended-release tablets. The hearing addresses concerns about the bioequivalence of Kremers' product to CONCERTA, particularly regarding therapeutic effect during the latter part of the 12-hour dosing period. The hearing will consider factual and legal information related to the withdrawal proposal, with key dates including a prehearing conference on September 28, 2026, and submission deadlines for participation and data disclosure.

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