Drug Approval | July 24, 2023
Lupin receives tentative USFDA’s approval for Dolutegravir Lamivudine and Tenofovir Alafenamide Tablets
This product would be manufactured at Lupin's Nagpur facility in India
This product would be manufactured at Lupin's Nagpur facility in India
Chlorpromazine Hydrochloride Tablets USP had an estimated annual sale of USD 45 million in the U.S.
Dolutegravir Tablets for Oral Suspension (RLD Tivicay PD®) had estimated annual sales of USD 1 million in the U.S. (IQVIA MAT March 2023)
The product will be manufactured at the group's formulation manufacturing facility in Baddi, Himachal Pradesh (India)
Alembic has a cumulative total of 184 ANDA approvals (159 final approvals and 25 tentative approvals) from USFDA.
Currently there are no vaccines approved anywhere in the world for gonorrhoea, and antimicrobial resistance to existing treatments is increasing
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12
The company will submit its comprehensive response on these observations to the USFDA
This product will be manufactured at Lupin's Pithampur facility in India
The group now has 372 approvals and has so far filed over 442* ANDAs since the commencement of the filing process in FY 2003-04.
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