Lupin Receives U.S. FDA Approval For Divalproex Sodium ER Tablets USP

Pharma major Lupin Limited (Lupin) announced that it has received approval for its Divalproex Sodium Extended-Release (ER ) Ta blets 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 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. (IQVIA MAT June 2019).

Shares of LUPIN LTD. was last trading in BSE at Rs.745.75 as compared to the previous close of Rs. 738.8. The total number of shares traded during the day was 44074 in over 1449 trades.

The stock hit an intraday high of Rs. 748 and intraday low of 733.95. The net turnover during the day was Rs. 32772968. – Equity Bulls