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Cipla receives final approval for generic Wellbutrin XL tablets

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They are indicated for the treatment of major depressive disorder (MDD) and prevention of seasonal affective disorder (SAD)

Cipla’s subsidiary, InvaGen Pharmaceuticals has received final approval for its abbreviated new drug application (ANDA) for Bupropion Hydrochloride Extended-Release Tablets (XL), 150 mg 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.

They 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.

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