BWI: Unichem Laboratories Receives ANDA Approval from USFDA for Divalproex Sodium Delayed Release Tablets

Press release from Business Wire India
Source: Unichem Laboratories Limited
Thursday, April 07, 2011 10:31 AM IST (05:01 AM GMT)
Editors: General: Consumer interest; Business: Advertising, PR & marketing, Business services, Chemicals, Healthcare, biotechnology & pharmaceutical, Information technology, Retailers; Technology; Healthcare
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Unichem Laboratories Receives ANDA Approval from USFDA for Divalproex Sodium Delayed Release Tablets


Mumbai, Maharashtra, India, Thursday, April 07, 2011 -- (Business Wire India) -- Unichem laboratories Limited are pleased to announce that it has received ANDA approval from the United States Food and Drug Administration (U.S. FDA) for Divalproex Sodium Delayed Release Tablets.

Divalproex Sodium Delayed Release Tablets USP 125mg, 250mg and 500mg (Valproic Acid Activity) are therapeutically equivalent to DEPAKOTE® Delayed-Release Tablets USP 125mg, 250mg, and 500mg from Abbott Laboratories. Divalproex Sodium formulations have annual sales of approximately USD 590 million in the US.

Divalproex Sodium Delayed-Release Tablets, USP are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. Divalproex Sodium Delayed-Release Tablets, USP also are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures. Divalproex Sodium Delayed-Release Tablets, USP also are indicated for the treatment of manic episodes associated with bipolar disorder and prophylaxis of migraine headaches.

The product will be commercialized from Unichem's Ghaziabad plant. This ANDA approval will increase the presence of Unichem in US market. Unichem already has 9 other ANDA's duly approved and there are some more ANDA's in pipeline.

About Unichem Laboratories Limited

Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India and several other markets across the world. In India, the company is a leader in niche therapy areas of cardiology, neurology, and orthopedics and anti-infectives. The company has strong skills in product development, process chemistry and manufacturing of complex API as well as dosage forms.

More information about the company can be found at www.unichemlabs.com .




CONTACT DETAILS
Mr. M Gundu Rao, Unichem Laboratories Limited, +91 (22) 66888380, gundurao@unichemlabs.com
Mr. Rakesh Parikh, Unichem Laboratories Limited , +91 (22) 66888414, rparikh@unichemlabs.com
Mr. K Subharaman, Unichem Laboratories Limited, +91 (22) 66888404, subharamank@unichemlabs.com

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CONSUMER, MARKETING, BUSINESS SERVICES, CHEMICALS, HEALTHCARE, IT, RETAIL, TECHNOLOGY, HEALTHCARE

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