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Ajanta Pharma receives US FDA approval for antidepressant drug duloxetine

The approved product is a generic version of Eli Lilly & Co's Cymbalta capsule

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Capsules

Last Updated : Jan 09 2017 | 5:31 PM IST

Ajanta Pharma Limited has received the final approval for duloxetine hydrochloride delayed release capsule, which is a generic version of Eli Lilly & Co’s Cymbalta, from US Food & Drug Administration (FDA). The company plans to launch the product shortly in 3 strengths, 20 mg, 30 mg and 60 mg strengths capsules.

Cymbalta (duloxetine), which is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI), is mostly prescribed for major depressive disorder, generalised anxiety disorder, fibromyalgia and neuropathic pain.

Duloxetine hydrochloride delayed release capsule is part of an ever growing portfolio of products that Ajanta has developed for the US market. In total, Ajanta has 32 abbreviated new drug applications (ANDAs) of which it has 17 final ANDA approvals, 2 tentative approvals and 13 ANDAs under review with US FDA.