Unichem Laboratories gets FDA approval for Dilantin generic

Unichem Laboratories Limited said that the US Food and Drug Administration (FDA) has approved its abbreviated new drug application (ANDA) for its Extended Phenytoin Sodium Capsules USP, 100 mg.

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

According to Unichem Laboratories, Extended Phenytoin Sodium Capsules have approval for the treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures as well as to prevent and treat seizures that occur during or after neurosurgery.

The Indian pharma company will manufacture the product from its Ghaziabad plant in Uttar Pradesh.