Lupin gets USFDA nod for generic equivalet of Dilantin

Extended Phenytoin Sodium Capsules USP,100 mg (RLD: Dilantin) had annual sales of approximately USD 105 million in the U.S. (IQVIA MAT June 2019), Lupin said.

New Delhi: Pharma major Lupin Limited (Lupin) recently announced that it has received approval for its Extended Phenytoin Sodium Capsules USP, 100 mg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Dilantin 100 mg, of Parke-Davis, division of Pfizer Inc.

Lupin’s Extended Phenytoin Sodium Capsules USP, 100 mg, are indicated for:

• Treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures


• Prevention and treatment of seizures occurring during or following neurosurgery

Extended Phenytoin Sodium Capsules USP,100 mg (RLD: Dilantin) had annual sales of approximately USD 105 million in the U.S. (IQVIA MAT June 2019).

Headquartered in Mumbai, the company is a significant player in Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds a global leadership position in the Anti-TB segment.

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