Sun Pharma gets USFDA approval for Depakote

Source: IRIS (14 February 2008)

Sun Pharma gets USFDA approval for Depakote
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Leading drug maker, Sun Pharmaceutical Industries announced that the USFDA granted tentative approval for the company`s abbreviated new drug application (ANDA) for generic Depakote, divalproex sodium delayed release tablets.

Divalproex sodium delayed release tablets are indicated as mono therapy 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 and activity) tablets are bio-equivalent to Depakotedelayed release tablets distributed by Abbott Laboratories. These strengths of Depakote® delayed release tablets have annual sales of approximately USD 755 million in the US.

Shares of the company gained Rs 19.25, or 1.77%, to settle at Rs 1,109.25. The total volume of shares traded was 6,466 at the BSE. (Thursday)



* Q - Quote , N - News , C - Chart , F - Financials


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