Lupin gets USFDA approval for Phenytoin Sodium Capsules

Lupin Limited has received approval from the United States Food and Drug Administration (USFDA) to market Extended Phenytoin Sodium Capsules USP, 100 mg, 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 and prevention and treatment of seizures occurring during or following neurosurgery.

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

On Monday, the company had announced the launch of Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg. Sildenafil Tablets are a phosphodiesterase-S (PDES) inhibitor and are indicated for the treatment of erectile dysfunction (ED).

Lupin Limited is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, Anti-effective and NSAID space and holds global leadership position in the Anti-TB segment.

On Tuesday, stock of Lupin opened at Rs. 720. During the day, it made intra-day high and low of Rs. 726.35 and Rs. 701.60 respectively. It got closed at Rs. 703.20, down by 1.7 per cent.