The Divalproex Sodium delayed release tablets USP 125mg, 250mg and 500mg (Valproic Acid Activity) are therapeutically equivalent to Abbott Laboratories’ Depakote delayed-release tablets USP 125mg, 250mg, and 500mg.
Divalproex Sodium delayed-release tablets are indicated as sole and adjunctive therapy for the treatment of complex partial seizures that occur either in isolation or in association with other types of seizures.
Further they are indicated for use as monotherapy and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types that include absence seizures.
They are also indicated for the treatment of manic episodes associated with bipolar disorder and prophylaxis of migraine headaches.
The ANDA approval is expected to increase the presence of Unichem in the US market.