The Food and Drug Administration has granted Kremers Urban Pharmaceuticals a formal hearing on a proposal to withdraw one generic drug approval. The proceeding matters because it could determine whether extended-release methylphenidate covered by application ANDA 091695 keeps its FDA approval.
Key Facts
- Current status: FDA has ordered an evidentiary hearing, but it has not withdrawn the application’s approval.
- Product: The proceeding concerns ANDA 091695 for four strengths of extended-release methylphenidate tablets.
- Next dates: Participation notices are due September 14, and a prehearing conference is scheduled for September 28.
What the hearing will decide
An evidentiary hearing is a formal administrative proceeding where parties present evidence on disputed factual or scientific questions. The central dispute is whether Kremers’ product has been shown bioequivalent to Concerta throughout the relevant therapeutic period.
Bioequivalent drugs must deliver their active ingredient without a significant difference under the applicable testing standards. Concerta’s approved labeling describes an expected 12-hour duration of effectiveness.
The hearing will focus on whether the Kremers product has been shown to provide comparable drug exposure across that period. It will particularly examine exposure during the later hours after a dose.
Administrative Law Judge Kourtney LeBlanc of the HHS Departmental Appeals Board will preside. The parties are Kremers and FDA’s Center for Drug Evaluation and Research, known as CDER.
Why CDER proposed withdrawal
FDA approved the application in 2013 for 18-, 27-, 36- and 54-milligram tablets. At that time, FDA found that Kremers had supplied enough data to demonstrate bioequivalence under the agency’s then-current approach.
FDA later received adverse-event reports describing insufficient therapeutic effect, especially during the latter part of the expected 12-hour period. Those reports prompted CDER to investigate the product and reconsider the evidence needed to establish bioequivalence.
CDER subsequently concluded that comparable exposure must be demonstrated throughout the therapeutic period. Applying its revised approach, CDER contends that Kremers’ data do not establish comparable exposure during certain later hours.
Those are CDER’s positions for the proceeding, not adjudicated findings. The hearing grant does not establish that the product is ineffective, unsafe or non-bioequivalent.
What Kremers says
Kremers contests the proposed withdrawal and timely requested a hearing in November 2016. It submitted supporting data, information and analyses in December 2017, followed by a supplement in May 2018.
Kremers therefore has not conceded CDER’s scientific position. Under the governing hearing rules, Kremers bears the burden of proof as the participant contesting withdrawal.
What changes now
The August 2026 notice starts the formal hearing stage; it does not withdraw approval, order a recall or ban the medication. The proceeding concerns only ANDA 091695, not every methylphenidate product or ADHD medication.
Interested people may seek to participate as nonparties by filing written notices by September 14, 2026. Kremers and other participants must submit specified evidence disclosures and narrative statements by October 13, unless the judge changes the schedule.
The prehearing conference will begin by videoconference at 10 a.m. Eastern time on September 28. The judge is expected to set the evidentiary-hearing date through that conference, so no hearing date is fixed yet.
The eventual administrative decision will address the disputed evidence and the proposed withdrawal. Until then, the notice leaves the merits unresolved.
