February 14, 2008: Sun Pharmaceutical Industries Ltd. announced that USFDA has 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 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 ® delayed release tablets distributed by Abbott Laboratories.
These strengths of Depakote ® delayed release tablets have annual sales of approximately USD 755 million in the US.
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