Drug Approval | November 08, 2023
Lupin receives USFDA tentative approval for Canagliflozin and Metformin Hydrochloride ER Tablets
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin’s Pithampur facility in India
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Glenmark's Zita portfolio of medicines have been benefiting around 1.75 million Type 2 diabetic patients annually
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
Lupin enters into BTA with Lupin Manufacturing Solutions
Biocon will be responsible for obtaining regulatory approval for Liraglutide, and thereafter, for the manufacture and supply of the product in the Canadian market
Sugammadex Injection is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
The approval adds to a list of products that Strides has approved in this therapeutic category through the PEPFAR pathway taking the total to 15 products
The product is bioequivalent and therapeutically equivalent to the RLD, Vascepa of Amarin
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