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
The product will be manufactured at Lupin’s Nagpur facility in India
This product will be manufactured at Lupin’s Pithampur facility in India
This product will be manufactured at Lupin's Nagpur facility in India
Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)
Lupin enters into BTA with Lupin Manufacturing Solutions
Lupin is exclusive first-to-file and may be eligible to receive a 180-day exclusivity period at product launch
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
The company has received six final approvals that includes Chlorpromazine Hydrochloride Tablets
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