Drug Approval | November 22, 2023
Lupin receives tentative approval from USFDA for Dapagliflozin Tablets
Dapagliflozin Tablets (RLD Farxiga) had estimated annual sales of USD 7282 million in the US
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
This product will be manufactured at Lupin’s Pithampur facility in India
Glenmark's current portfolio consists of 188 products authorized for distribution in the US
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
Approval of this product under the PEPFAR program completes Strides’ qualification to all major markets and donor programs including Global Fund and South Africa
The products will be manufactured at the company's facility in Bengaluru
Erythromycin tablets is used to prevent and treat infections in many different parts of the body
Prasugrel tablets are indicated to reduce the rate of thrombotic CV events
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