Opportunity
Federal Register #ANDA 091695
FDA Public Hearing on Withdrawal of Approval for Kremers Urban Pharmaceuticals' Generic CONCERTA (ANDA 091695)
Buyer
Food and Drug Administration
Posted
August 13, 2026
Respond By
September 14, 2026
Identifier
ANDA 091695
This FDA event is a formal public hearing to consider withdrawing approval of Kremers Urban Pharmaceuticals' generic methylphenidate hydrochloride extended-release tablets (ANDA 091695). - Regulatory context: - FDA proposes withdrawal due to failure to demonstrate bioequivalence with CONCERTA over the full 12-hour therapeutic window - Hearing will address scientific and factual issues regarding therapeutic equivalence - Products involved: - Methylphenidate hydrochloride extended-release tablets (generic CONCERTA) in 18 mg, 27 mg, 36 mg, and 54 mg strengths - Reference product: CONCERTA by Janssen Pharmaceuticals - No procurement or solicitation: - This is not a contracting or purchasing opportunity - No products or services are being requested - Additional information: - NIH's National Heart, Lung, and Blood Institute is offering licensing for novel spironolactone analogues as anti-inflammatory therapeutics - Licensing opportunity is referenced but not solicited - Key stakeholders: - FDA Center for Drug Evaluation and Research - Kremers Urban Pharmaceuticals, Inc. - Janssen Pharmaceuticals, Inc. (reference product manufacturer) - Focus is on regulatory compliance, bioequivalence, and therapeutic effect, not business procurement
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 FDA's Center for Drug Evaluation and Research (CDER) proposed withdrawal due to failure to demonstrate bioequivalence to the reference drug CONCERTA during the entire 12-hour therapeutic time course. The hearing will address factual issues regarding bioequivalence and the therapeutic effect of the Kremers product compared to CONCERTA.