USFDA grants Sun Pharma tentative marketing approval for generic Cymbalta

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Nov 24 2010

Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) announced that USFDA has granted its subsidiary a tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Cymbalta®, duloxetine hydrochloride delayed-release capsules.

These generic duloxetine hydrochloride delayed-release capsules, 20 mg (base), 30 mg (base), and 60 mg (base) are indicated in the treatment of Major Depressive Disorder (MDD), Generalized Anxiety Disorder (GAD) and Diabetic Peripheral Neuropathic Pain (DPNP).

Cymbalta® has annual sale of approximately $ 3 billion in the US.

Cymbalta® is a registered trademark of Eli Lilly & Company.

SOURCE Sun Pharmaceutical Industries Ltd.

Posted in: Medical Condition News | Pharmaceutical News

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