Drug Approval | October 07, 2023
Lupin receives tentative approval from USFDA for Tolvaptan Tablets
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
Tolvaptan Tablets (RLD Jynarque) had estimated annual sales of USD 287 million in the U.S. (IQVIA MAT August 2023)
This product would be manufactured at Lupin's Nagpur facility in India
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).
The approval for Glycopyrrolate clears the path for more internally manufactured injectable products
DETAF would be a welcome new addition in the management of HIV infections and will be available for supplies to low- and middle-income countries
Ivacaftor Tablets had estimated annual sales of USD 109 million in the US.
This product will be manufactured at Lupin’s Nagpur facility in India
Brivaracetam tablets are indicated for the treatment of partial-onset seizures in patients four years of age and older
TLD is recommended by WHO, USAID, and PEPFAR as a preferred first-line treatment regimen for the treatment of HIV in adults and pediatric patients weighing at least 35 kg
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