Cipla Ltd, a Rs. 13,350 crore plus global pharma company, has announced that its subsidiary, InvaGen Pharmaceuticals Inc. (collectively Cipla), has received final approval for its Abbreviated New Drug Application (ANDA) for bupropion hydrochloride extended- release tablets (XL), 150mg and 300mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Valeant’s Wellbutrin XL tablets, 150mg and 300mg.
Cipla’s bupropion hydrochloride extended-release tablets (XL), 150mg and 300mg, are AB-rated generic equivalents of Valeant’s Wellbutrin XL tablets, 150mg and 300mg, 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 $792M for the 12 month period ending June 2016, according to IMS Health.