Mumbai, IndiaIndia-based Unichem Laboratories recently received approval from the US Food and Drug Administration (FDA) to market its divalproex sodium delayed-release tablets, a generic form of Depakote.
According to a release from the pharmaceutical company, other forms of the tablets have annual sales of approximately $590 million in the US.
The medication is reportedly used in the treatment of patients with complex partial seizures that occur either on an isolated basis or in conjunction with other forms of seizure, the release stated. The treatment also received approval in the treatment of manic episodes that are generally associated with bipolar disorder.
The product will reportedly be manufactured at the company's plant in Ghaziabad, India, according to the release.
In addition to the FDA approval, the medication reportedly received an Abbreviated New Drug Application (ANDA) approval, which will allow the pharmaceutical company to increase its presence on the US market, the release said. Unichem already has nine other approved applications, the company said.
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