Drug Approval | November 24, 2023
Lupin receives tentative approval from USFDA for Canagliflozin Tablets
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor
Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor
Bromfenac Ophthalmic Solution, 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
Pitavastatin Tablets are indicated as an adjunct to diet to reduce low-density lipoprotein cholesterol
The product will be manufactured at Lupin’s Nagpur facility in India
Rocuronium Bromide Injection had estimated annual sales of USD 54 million in the US (IQVIA MAT August 2023).
This product will be manufactured at Lupin’s Pithampur facility in India
The inspection of the facility conducted from August 7 to August 11, 2023
Approval of oral, once-daily VELSIPITY based on favorable safety and efficacy data from the ELEVATE UC Phase 3 trials
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
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