Health and Human Services Department, Food and Drug Administration
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.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2016-N-3120] AGENCY: Food and Drug Administration, HHS. ACTION: 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. DATES: A prehearing conference will be held on September 28, 2026, beginning at 10:00 a.m. Eastern Daylight Time. Any person wishing to participate in this hearing shall submit a written notice of participation by September 14, 2026. Disclosure of data and information as required by 21 CFR 12.85(b) must be made by October 13, 2026. ADDRESSES: You may submit a written notice of participation and data and information required under 21 CFR 12.85 by either of the following methods: Electronic Submissions Submit electronically in the following way: Federa…
Other Federal Register documents from the same docket.
Citation: 91 FR 52307
