Lupin gets FDA nod for generic Depakote

Lupin has received the Food and Drug Administration’s green light for divalproex sodium extended-release tablets, in dosage strengths of 250 mg and 500 mg.

The product is the generic of AbbVie’s Depakote extended-release tablets, 250 mg and 500 mg.

It is 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.

Divalproex sodium ER tablets, 250 mg and 500 mg had a market value of roughly $159 million, according to IQVIA June 2019 data.