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Lupin receives US FDA approval for Divalproex Sodium ER Tablets USP

The approval is for marketing 250 mg and 500 mg tablets

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Lupin 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 (US 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; and prophylaxis of migraine headaches.

Acccording to IQVIA MAT June 2019, 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 US.

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