Unichem Laboratories receives US FDA approval for divalproex sodium

Unichem Laboratories yesterday said it has received approval from the US health regulator to market its generic version of Divalproex Sodium extended-release tablets used for treatment of bipolar disorder and migraine.

The approval by the US Food and Drug Administration (FDA) is for the Abbreviated New Drug Application (ANDA) of Divalproex Sodium extended-release tablets of strengths 250 mg and 500 mg, Unichem Laboratories said in a regulatory filing.

These are the generic equivalent of Depakote ER (Divalproex Sodium) extended-release tablets 250 mg and 500 mg, of AbbVie Inc, it added.

The tablets are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, as monotherapy and adjunctive therapy and prophylaxis of migraine headaches, the company said.

The product will be commercialised from Unichem’s Goa plant, it added.