Lupin's arm receives USFDA approval for generic Cymbalta Delayed-release capsules

09 Dec 2011 Evaluate

Pharma Major, Lupin’s US subsidiary - Lupin Pharmaceuticals, Inc. (LPI) has received tentative approval for its Duloxetine Hydrochloride Delayed-release (HCL DR) Capsules 20 mg, 30 mg and 60 mg from the United States Food and Drugs Administration (USFDA) for the company's Abbreviated New Drug Application (ANDA) to market a generic version of Eli Lily & Company's Cymbalta Delayed-release Capsules.

Lupin's Duloxetine HCL DR Capsules are the AB-rated generic equivalent of Eli Lily's Cymbalta Delayed-release Capsules 20 mg, 30 mg and 60 mg strengths. Duloxetine HCL DR Capsules is indicated for the treatment of major depressive disorder (MDD), generalized anxiety disorder (GAD), management of neuropathic pain. (DPNP) associated with diabetic peripheral neuropathy, management of fibromyalgia (FM) and management of chronic musculoskeletal pain.

Cymbalta HCL DR Capsules 20 mg, 30 mg, 60 mg had annual US sales of approximately $33 billion for the twelve months ending September, 2011 as per IMS Health data.

Lupin has a vibrant presence in the Indian pharmaceuticals market and has over the past several years made major strides in expanding its therapy portfolio. The company has a robust promotion and distribution setup along with a strong presence in various therapeutic areas, including the fast growing diabetes market.

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