Lupin receives USFDA approval for Divalproex Sodium ER Tablets USP

Lupin has 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 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 mg are 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 annual sales of approximately USD 159 million in the U.S.