Opportunity
Federal Register #2026-12236
FDA Withdrawal of Approval for SpecGx LLC's Methylphenidate Hydrochloride Extended-Release Tablets
Buyer
Food and Drug Administration
Posted
June 18, 2026
Identifier
2026-12236
This notice concerns the FDA's regulatory action regarding a specific pharmaceutical product. - Government buyer: Food and Drug Administration (FDA), Department of Health and Human Services - OEMs mentioned: - SpecGx LLC (holder of the withdrawn ANDA) - Janssen Pharmaceuticals (manufacturer of the reference listed drug, CONCERTA) - Products referenced: - Methylphenidate Hydrochloride Extended-Release Tablets, 27 mg, 36 mg, 54 mg (SpecGx LLC, ANDA 202608) - CONCERTA (Janssen Pharmaceuticals, reference listed drug) - Notable requirements and details: - FDA determined SpecGx's product was not bioequivalent to CONCERTA, especially regarding therapeutic effectiveness over 12 hours - SpecGx LLC requested withdrawal of its ANDA and waived its right to a hearing - This is a regulatory withdrawal notice, not a procurement or contract opportunity
Description
The Food and Drug Administration (FDA) is withdrawing approval of abbreviated new drug application (ANDA) 202608 for Methylphenidate Hydrochloride Extended-Release tablets in strengths of 27 mg, 36 mg, and 54 mg, held by SpecGx LLC. SpecGx requested the withdrawal and waived its opportunity for a hearing. The withdrawal is effective as of June 18, 2026. This action follows FDA's determination that the product had not been shown to be bioequivalent to the reference listed drug CONCERTA, raising concerns about therapeutic effectiveness.