Lupin receives FDA approval for generic Gabapentin Tablets USP, 600 mg and 800 mg

Deepthi | Myequity news | Date : 28-08-2018 13:00:00 IST

Pharma major Lupin announced that it has received final approval for its Gabapentin Tablets USP, 600 mg and 800 mg from the United States Food and Drug Administration (FDA) to market a generic version of Pfizer Inc.’s Neurontin® Tablets, 600 mg and 800 mg. Gabapentin Tablets USP, 600 mg and 800 mg had annual sales of approximately USD 180.7 million in the US (IQVIA MAT June 2018).

Lupin’s Gabapentin Tablets USP, 600 mg and 800 mg is the generic version of Pfizer’s Neurontin® Tablets, 600 mg and 800 mg. It is indicated for the treatment of postherpetic neuralgia in adults and adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.

About Lupin Limited:

Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.

Lupin is the 8th largest generics pharmaceutical company both in terms of market capitalization (301h June 2018, Bloomberg) and revenues (31" March 2018, Bloomberg LTM) globally. The Company is the 4th largest pharmaceutical player in the US by prescriptions (IQVIA MAT June 2018); 3rd largest Indian pharmaceutical company by global revenues (31' March 2018, Bloomberg LTM); 5th largest generic pharmaceutical player in Japan and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT June 2018).For the financial year ended 31st March, 2018, Lupin's Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.

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