Lupin gets USFDA nod for generic equivalent of Depakote ER Tablets to treat epilepsy in US

"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 said in its recent release.

Mumbai: Pharma major Lupin Limited (Lupin) recently announced that it has received approval from the US health regulator for its Divalproex Sodium Extended-Release (ER) Tablets USP,250 mg and 500 mg, indicated for the treatment of manic, seizure and Prophylaxis of migraine headaches.

"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 said in its recent release.

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 MATJune2019).

Lupin develops and delivers a range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a global position in the Anti-TB segment.

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