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Results For "approval"

2608 News Found

Alembic announces USFDA final approval for Icatibant injection
Drug Approval | June 17, 2024

Alembic announces USFDA final approval for Icatibant injection

This is the first peptide product approval from the USFDA received by Alembic Pharmaceuticals


Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets
Drug Approval | June 14, 2024

Zydus receives USFDA’s tentative approval for Azilsartan Medoxomil and Chlorthalidone Tablets

Azilsartan Medoxomil and Chlorthalidone Tablets had annual sales of US$ 77.9 mn in the United States (IQVIA MAT March 24).


Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules
Drug Approval | June 12, 2024

Glenmark receives ANDA approval for Esomeprazole Magnesium Delayed-Release capsules

Glenmark's current portfolio consists of 197 products authorized for distribution in the U.S. marketplace


Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets
Drug Approval | June 07, 2024

Indoco Remedies receives tentative ANDA approval for Canagliflozin, Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets are used to treat type 2 diabetes mellitus


Orchid Pharma receives DCGI approval for combination of Cefepime and Enmetazobactam
Drug Approval | June 07, 2024

Orchid Pharma receives DCGI approval for combination of Cefepime and Enmetazobactam

DCGI has also granted permission to manufacture and market FDF of Cefepime and Enmetazobactam as a dry powder injectable


AstraZeneca’s Tagrisso plus chemo recommended for approval in EU
Drug Approval | June 05, 2024

AstraZeneca’s Tagrisso plus chemo recommended for approval in EU

Recommendation based on FLAURA2 results which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly 9 months


Cupid receives vendor approval from Godrej Consumer for Supply of Kamasutra condoms
News | June 01, 2024

Cupid receives vendor approval from Godrej Consumer for Supply of Kamasutra condoms

This significant achievement includes an initial order from GCPL valued at a substantial Rs. 2.4 crore


Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA
Drug Approval | June 01, 2024

Moderna receives U.S. FDA approval for RSV Vaccine mRESVIA

mRESVIA is Moderna's second approved product and the only RSV vaccine available in single-dose pre-filled syringes


Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets
Drug Approval | May 30, 2024

Alembic Pharmaceuticals receives USFDA final approval for Sacubitril and Valsartan Tablets

Sacubitril and Valsartan Tablets are indicated to reduce the risk of cardiovascular death


Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL
Drug Approval | May 29, 2024

Strides receives USFDA approval for Sucralfate oral suspension, 1gm/10 mL

Strides’ approval for this product marks the 1st Indian approval from the USFDA for this complex formulation