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Tag: usfda

You Searched For "usfda"
Lupin alliance partner Concord gets USFDA nod to generic version of CellCept Tablets

Lupin alliance partner Concord gets USFDA nod to generic version of CellCept Tablets

Ruchika Sharma8 Aug 2020 9:30 AM IST
Mumbai: Pharma major Lupin Limited in alliance with Concord Biotech Limited has announced that it has received approval from the United...
Alembic Pharma Vardenafil Hydrochloride Tablet gets USFDA nod to treat erectile dysfunction

Alembic Pharma Vardenafil Hydrochloride Tablet gets USFDA nod to treat erectile dysfunction

Ruchika Sharma6 Aug 2020 12:53 PM IST
Vardenafil Hydrochloride Tablets are indicated for the treatment of erectile dysfunction.
Abacavir, Dolutegravir and Lamivudine Tablets for Oral Suspension

Lupin gets tentative USFDA nod for diabetes drug Empagliflozin

Ruchika Sharma5 Aug 2020 11:40 AM IST
Mumbai, Baltimore: Pharma major Lupin Limited has announced that it has received tentative approval for its Empagliflozin Tablets, 10 mg...
Zydus Cadila gets USFDA tentative nod to market Parkinsons disease drug

Zydus Cadila gets USFDA tentative nod to market Parkinson's disease drug

Ruchika Sharma3 Aug 2020 10:00 AM IST
Ahmedabad: Zydus Cadila has received tentative approval from the USFDA to market Carbidopa and Levodopa Extended-Release Capsules (US RLD - Rytary®)...
Roche Itovebi recommended by CHMP for EU approval for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer

FDA nod to Roche's Tecentriq plus Cotellic and Zelboraf in advanced melanoma

Ruchika Sharma3 Aug 2020 9:30 AM IST
Basel: Roche has announced that the U.S. Food and Drug Administration (FDA) approved Tecentriq® (atezolizumab) plus Cotellic® (cobimetinib)...
Lumos Pharma to sell its Priority Review Voucher ERVEBO to MSD

Lumos Pharma to sell its Priority Review Voucher ERVEBO to MSD

Ruchika Sharma2 Aug 2020 9:30 AM IST
Based upon an agreed valuation of $100 million Merck will pay Lumos $60 million
PharmaCyte Biotech submits Drug Master File to USFDA for Pancreatic Cancer Therapy

PharmaCyte Biotech submits Drug Master File to USFDA for Pancreatic Cancer Therapy

Ruchika Sharma2 Aug 2020 9:00 AM IST
Laguna Hills: PharmaCyte Biotech, Inc., a biotechnology company focused on developing cellular therapies for cancer and diabetes using its...
Merck HIF-2α Inhibitor MK-6482 gets Breakthrough Therapy Designation from USFDA

Merck HIF-2α Inhibitor MK-6482 gets Breakthrough Therapy Designation from USFDA

Ruchika Sharma31 July 2020 9:00 AM IST
Kenilworth: Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has granted...
Dr Reddys Labs gets USFDA nod for lice treatment lotion XEGLYZE in US

Dr Reddy's Labs gets USFDA nod for lice treatment lotion XEGLYZE in US

Ruchika Sharma28 July 2020 12:42 PM IST
XEGLYZE is indicated for the topical treatment of head lice infestation in patients 6 months of age and older.
Zydus Cadila Desidustat gets USFDA nod to initiate clinical trials on cancer patients

Zydus Cadila Desidustat gets USFDA nod to initiate clinical trials on cancer patients

Ruchika Sharma24 July 2020 1:33 PM IST
Ahmedabad: Zydus has received approval from the USFDA, to initiate clinical trials of Desidustat in Chemotherapy Induced Anemia...
Lupin gets tentative USFDA approval for diabetes drugs Empagliflozin, Linagliptin

Lupin gets tentative USFDA approval for diabetes drugs Empagliflozin, Linagliptin

Ruchika Sharma24 July 2020 12:19 PM IST
Empagliflozin and Linagliptin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes...
Unichem Labs irregular heartbeat drug Amiodarone gets USFDA approval

Unichem Labs irregular heartbeat drug Amiodarone gets USFDA approval

Ruchika Sharma23 July 2020 12:05 PM IST
Mumbai: Unichem Laboratories Limited has received ANDA approval for its Amiodarone Tablets, USP, 200 mg from the United States Food and Drug ...
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