Lupin gets USFDA nod to market its mania and epilepsy treatment drug in US

NEW DELHI: Drug firm Lupin on Tuesday said it has received approval from the US health regulator to market its generic Divalproex Sodium extended-release tablets in the American market.
The company has received approval from the United States Food and Drug Administration (USFDA) for its Divalproex Sodium extended-release tablets in the strengths of 250 mg and 500 mg, Lupin said in a statement.

The company's product is a generic version of AbbVie Inc's Depakote extended-release tablets in the same strengths, it added.

As per IQVIA MAT June 2019 data, Divalproex sodium extended-release (ER) tablets USP, 250 mg and 500 mg had annual sales of approximately USD 159 million (over Rs 1,100 crore) in the US, Lupin said.

The tablets are indicated for treatment of manic or mixed episodes associated with bipolar disorder with or without psychotic features, prophylaxis of migraine headaches and for treatment of complex partial seizures and simple and complex absence seizures, it added.

Shares of Lupin on Tuesday closed at Rs 745.75 per scrip on the BSE, up 0.94 per cent from its previous close.