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# FDA Grants Lupin Tentative Approval for Generic Paxil
- URL: https://www.fdaweb.com/fda-grants-lupin-tentative-approval-for-generic-paxil/
- Published: 2016-08-26T12:00:00.000Z
- Updated: 2026-09-14T21:27:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136631

FDA has granted Lupin Ltd. tentative approval for its ANDA for paroxetine extended-release tablets, 12.5 mg, 25mg and 37.5 mg, generic copies of GlaxoSmithKline’s anti-depressant Paxil CR. “The tentative approval letter delays final approval of the generic drug product until all patent or exclusivity issues has been resolved,” FDA told Lupin. Paxil is approved for treating major depressive disorder, panic disorder, social anxiety disorder and premenstrual dysphoric disorder.