Lupin gets USFDA nod for generic drug to treat HIV infection

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

69
USFDA Drug product Approval
USFDA Approval

Last Updated on December 31, 2023 by The Health Master

Global pharma major Lupin Limited has received approval for its emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Truvada tablets, 200 mg/300 mg, of Gilead Sciences, Inc.

Emtricitabine and tenofovir disoproxil fumarate tablets, 200 mg/300 mg, are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The product will be manufactured at Lupin’s facility in Nagpur, India.. It is also used for for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection.

Emtricitabine and tenofovir disoproxil fumarate tablets had estimated annual sales of US$ 2.1 billion in the US, according to IQVIA MAT March 2021)

Glenmark gets USFDA nod for Theophylline ER tablets

Zydus Cadila gets tentative USFDA nod for Osimertinib Tablets

Zydus Cadila gets USFDA nod for Fluphenazine HCL Tablets

Glenmark gets USFDA nod for Icatibant injection single-dose prefilled syringe

NATCO Pharma gets USFDA nod for Everolimus tablets

Natco Pharma gets USFDA nod for Lenalidomide capsules

Schedules – Drugs and Cosmetics Act 1940 and Rules 1945

Niclosamide: Phase II clinical trial begins for the treatment of C-19

60 million doses of Sputnik V vaccine to be supplied to…

Dr Reddy’s recalls 2,980 bottles of Atorvastatin Calcium tablets

Dos and don’ts of CT scanning in C-19

Recovered C-19 patients must take this medicine for 2-3 months

For informative videos by The Health Master, click on the below YouTube icon:

YouTube Icon

For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:

YouTube Icon

For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:

YouTube Icon

For informative videos on consumer awareness, click on the below YouTube icon:

YouTube Icon
Telegram
WhatsApp
Facebook
LinkedIn
YouTube Icon
Google-news