United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2026_register executive 2026-08-13 article Notices D09002ee1e6b6c379 D09002ee1e6b6c4db United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency 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. 91 FR 52307 https://www.govinfo.gov/app/details/FR-2026-08-13/2026-16536 2026-16536 fr13au26-49 4164-01-P Docket No. FDA-2016-N-3120 https://www.govinfo.gov/app/details/FR-2026-08-13/2026-16536 https://www.govinfo.gov/content/pkg/FR-2026-08-13/html/2026-16536.htm https://www.govinfo.gov/content/pkg/FR-2026-08-13/pdf/2026-16536.pdf 4 p. 52307 52310 91 FR 52307 Kremers Urban Pharmaceuticals, Inc.; Grant of Hearing Request Regarding a Proposal To Withdraw Approval of an Abbreviated New Drug Application for Extended-Release Methylphenidate Tablets; Federal Register Vol. 91, Issue NOTICE 2026-16536 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2026-09-28 Docket No. FDA-2016-N-3120 4164-01-P 2026-16536 Notice.

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.

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. Karen Fikes, Office of Scientific Integrity, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 1, Rm. 4218, Silver Spring, MD 20993, 301-796-9603. Withdrawal of Approval of Drug Application Kremers Urban Pharmaceuticals, Inc., Extended-Release Methylphenidate Tablets; Grant of Hearing Request, https://dab.efile.hhs.gov/ https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov www.hhs.gov/live Vol. 91, no. 155 Office of the Federal Register, National Archives and Records Administration 2026-08-13 continuing daily deposited born digital 264 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2026-08-13 P0b002ee1e6b1d555 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr13au26 https://www.govinfo.gov/app/details/FR-2026-08-13 https://www.govinfo.gov/content/pkg/FR-2026-08-13/pdf/FR-2026-08-13.pdf https://www.govinfo.gov/content/pkg/FR-2026-08-13/xml/FR-2026-08-13.xml fdlp 52219 52474 DGPO 2026-08-13 2026-08-13 FR-2026-08-13 machine generated eng FR FR-2026-08-13 91 155