Sun Pharma Gets USFDA Approval for Generic Depakote (R) Delayed Release Tablets.
MUMBAI, July 30 /PRNewswire/ -- Sun Pharmaceutical Industries Ltd. announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) for generic Depakote (R), divalproex sodium delayed release tablets.
Divalproex sodium delayed release tablets are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures, as sole and adjunct therapy for patients with simple and complex absence seizures, for the treatment of the manic episodes associated with bipolar disorders, as well as for prophylaxis of migraine headaches.
These generic versions of divalproex sodium delayed release 125 mg, 250 mg and 500 mg (valproic acid activity) tablets are bio-equivalent to Depakote (R) delayed release tablets distributed by Abbott Laboratories.
These strengths of Depakote (R) delayed release tablets have annual sales of approximately USD 750 million in the US.
These products will reach market shortly.
Depakote (R) is a registered trademark of Abbott Laboratories.
About Sun Pharmaceutical Industries Ltd.
Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries Ltd. (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE:SUNPHARMA, BSE: 524715) is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, diabetology, gastroenterology, and orthopaedics. 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 http://www.sunpharma.com.
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