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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...
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.
Read also: Unichem Labs Chairman says pharma sector recovery may get delayed but not derailed
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.
Read also: Unichem Labs anticonvulsant drug Carbamazepine gets USFDA okay
Ruchika Sharma joined Medical Dialogue as an Desk Editor for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751