FDA Okays Hearing for Kremers' Fight to Save Generic ADHD Med Approval
Published Date: 8/13/2026
Notice
Summary
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.
Analyzed Economic Effects
2 provisions identified: 0 benefits, 2 costs, 0 mixed.
FDA found late‑day bioequivalence failures
The FDA says it received adverse event reports that Kremers' methylphenidate product had insufficient therapeutic effect late in the 12‑hour dosing period. CDER reanalyzed Kremers' data and concluded the product failed to show an absence of a significant difference in drug exposure versus CONCERTA during the 7–12 hour period fasting and the 8–12 hour period under fed conditions, and new data submitted in June 2015 also failed for the 8–12 hour fed window.
Hearing on possible withdrawal of generic
If you take Kremers’ generic version of CONCERTA (approved as ANDA 091695), the FDA has proposed to withdraw approval of that ANDA and is holding a formal evidentiary hearing. A prehearing conference is scheduled for September 28, 2026; written notices of participation must be filed by September 14, 2026, and disclosures of data must be made by October 13, 2026.
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