Unichem Labs bags USFDA nod for Extended Phenytoin Sodium Capsules

Mumbai: Unichem Laboratories Limited has announced that the company has received abbreviated new drug application (ANDA) approval for its Extended Phenytoin Sodium Capsules USP, 100 mg from the United States Food and Drug Administration (USFDA).

The product is a generic version of Dilantin (Phenytoin Sodium) Capsules, 100 mg, of Viatris Specialty LLC.

Extended Phenytoin Sodium Capsules are indicated for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery.

The product will be commercialized from Unichem's Ghaziabad Plant.

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Unichem Laboratories Limited is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in several markets across the world.

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