Lupin gets USFDA approval for generic Gabapentin Tablets

Lupin Limited has announced that it has received final approval for its Gabapentin Tablets USP, 600 mg and 800 mg from the USFDA to market a generic version of Pfizer Inc.’s Neurontin Tablets, 600 mg and 800 mg.

This generic version of tablets is indicated for the treatment of postherpetic neuralgia in adults and adjunctive therapy in the treatment of partial onset seizures. It is also prescribed to adults and pediatric patients with epilepsy, with or without secondary generalisation.

Gabapentin Tablets USP, 600 mg and 800 mg had an annual sales of approximately US$180.7 million in the US market.

Also, on Monday, the company had announced the launch of Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg (EQ Beyaze), for which it has already received approval from USFDA. These tablets are the generic equivalent of Bayer’s Beyaz tablets. It is indicated to be used by women for preventing pregnancy and treat symptoms of disorders arising from the use of oral contraception.

Since the past two weeks, company’s stock has jumped by ~12 percent from Rs. 811.25 to Rs. 907.65 per share on BSE. On Tuesday, the stock opened at Rs. 910.10, and surged by 1.3 percent to make intra-day high of Rs. 919 per share.