Last Updated on October 15, 2024 by The Health Master
Global pharma major Lupin Limited announced that it has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application for Tenofovir Alafenamide Tablets, 25 mg.
It is a generic equivalent of Vemlidy Tablets, 25 mg, of Gilead Sciences, Inc. This product will be manufactured at Lupin’s Nagpur facility in India.
The drug is approved for the treatment of chronic Hepatitis B infection in adults.
Tenofovir Alafenamide Tablets, 25 mg, (RLD Vemlidy) had estimated annual sales of USD 531 million in the U.S. (IQVIA MAT December 2022).
USFDA gives approval for Brimonidine Tartrate Ophthalmic Solution, 0.15%
USFDA gives ANDA approval for Gabapentin tablets
USFDA gives tentative approval for Valbenazine capsules
USFDA gives approval for Obeticholic acid tablets
USFDA gives approval for this Antifungal drug
USFDA grants accelerated approval for Skin cancer therapy
Govt constitutes expert committee to review Pharmacy Act
Govt announces custom duty relief for rare disease drugs
Pharmacies to be set up at 270 stations in Railway
USFDA issues Form 483 with 10 observations to Lupin, Pithampur
NPPA fixed retail price of 25 formulations: March 2023
CDSCO gives marketing approval for this Diabetes drug in pre-filled pen
Remdesivir not a wonder drug, affects heart: Study
Drug recall: 55,000 bottles of Colchicine tablets due to this reason
Difference: Disintegration and Dissolution test in pharma industry
How to prepare SOPs in the Pharma Industry
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon: