U.S. FDA approved Lupin's Divalproex Sodium Extended-Release (ER) Tablets

Lupin Limited 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.

Divalproex Sodium ER Tablets will be helpful in treatment of manic or mixed episodes associated with bipolar disorder (with or without psychotic features), prophylaxis of migraine headaches as well as in treatment of 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. This tablet had annual sales of approximately USD 159 million in the U.S. according to IQVIA MAT as on June 2019.

Lupin is a pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APis globally. The company is a key player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, Gl, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

 On Wednesday, the stock of Lupin opened at Rs. 747.90 per share and made an intraday high and low of Rs. 748.05 and Rs. 730.85, respectively on the BSE. The stock closed at Rs. 736, down by 1.31 per cent.