India: Pharmaceuticals Cipla Receives Final Approval for Generic Wellbutrin XL Tablets

Editor: Dominik Stephan

Cipla, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, announced that its subsidiary, InvaGen Pharmaceuticals Inc.(collectively Cipla), has received final approval its Abbreviated New Drug Application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL), 150mg and 300 mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Valeant’s Wellbutrin XL Tablets, 150 mg and 300 mg.

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Mumbai/India – Cipla’s Bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg and 300 mg, are AB-rated generic equivalents of Valeant’s Wellbutrin XL Tablets, 150 mg and 300 mg, and are indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD). The product is available for shipping immediately.

Earlier Cipla-InvaGen ANDA approvals include Bupropion Hydrochloride Extended-Release Tablets (SR) and Trospium Chloride Tablets. Wellbutrin XL Tablets and generic equivalents had US sales of approximately $792 million for the 12 month period ending June 2016, according to IMS Health.