Lupin gets USFDA’s tentative nod for Canagliflozin, Metformin Hydrochloride Extended-Release Tablets

07 Nov 2023 Evaluate

Lupin has received tentative approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Canagliflozin and Metformin Hydrochloride Extended-Release Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg to market a generic equivalent of Invokamet XR Tablets, 50 mg/500 mg, 50 mg/1,000 mg, 150 mg/500 mg, and 150 mg/1,000 mg, of Janssen Pharmaceuticals, Inc. This product will be manufactured at Lupin’s Pithampur facility in India.

Canagliflozin and Metformin Hydrochloride Extended-Release Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Canagliflozin and Metformin Hydrochloride Extended-Release Tablets (RLD Invokamet XR) had estimated annual sales of $28 million in the U.S. (IQVIA MAT July 2023).

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


Lupin Share Price

2083.30 -28.70 (-1.36%)
01-Jan-2026 10:47 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1710.85
Dr. Reddys Lab 1253.65
Cipla 1503.15
Zydus Lifesciences 910.00
Lupin 2083.30
View more..
Register Now to get our Free Newsletter & much more!

© 2026 The Alchemists Ark Pvt. Ltd. All rights reserved. MoneyWorks4Me ® is a registered trademark of The Alchemists Ark Pvt. Ltd.

×