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HHS FDA Withdraws Approval of SpecGx Generic Concerta Tablets
June 18, 2026
WASHINGTON, June 18 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration said it is withdrawing approval of an abbreviated drug application held by SpecGx LLC, Webster Groves, Missouri, for Methylphenidate Hydrochloride Extended-Release tablets in 27 mg, 36 mg and 54 mg strengths after concluding that the products had not been shown to be bioequivalent to the brand-name drug Concerta.

The agency said the application, identified as ANDA 202608, was . . .

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