Pharma major Lupin Limited (Lupin) announced that it has received approval for its Divalproex Sodium Extended-Release (ER) Tablets USP,250 mg and 500 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Depakote®Extended-Release Tablets, 250 mg and 500 mg, of AbbVie Inc.

Lupin’s Divalproex Sodium ER Tablets USP, 250 mg and 500 mgare indicated for:

Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches

Divalproex Sodium Extended-Release (ER) Tablets USP, 250 mg and 500 mg(RLD: Depakote® ER)had annualsales ofapproximatelyUSD159million in the U.S. (IQVIA MATJune2019).