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Results For "USFDA"

1134 News Found

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution
Drug Approval | March 04, 2023

Zydus receives final approval from the USFDA for Vigabatrin for Oral Solution

Vigabatrin for Oral Solution USP, 500 mg had annual sales of USD 233.7 mn in the United States


Zydus receives final approval from the USFDA for Acyclovir Cream
Drug Approval | March 03, 2023

Zydus receives final approval from the USFDA for Acyclovir Cream

he product will be launched shortly in the US market.


Zydus receives final approval from the USFDA for Apixaban Tablets
Drug Approval | March 01, 2023

Zydus receives final approval from the USFDA for Apixaban Tablets

Apixaban Tablets, 2.5 mg and 5 mg had annual sales of USD 18,876 mn in the United States (IQVIA MAT Dec. 2022).


Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets
Drug Approval | March 01, 2023

Zydus receives final approval from the USFDA for Hydrochlorothiazide Tablets

This combination medicine is used to treat high blood pressure (hypertension).


Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg
Drug Approval | February 27, 2023

Granules India gets USFDA approval for Losartan Potassium Tablets USP, 25 mg, 50 mg, and 100 mg

Losartan potassium tablets are indicated for the treatment of hypertension in adults and pediatric patients 6 years of age and older, to lower blood pressure.


USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review
Drug Approval | February 22, 2023

USFDA accepts biologics license application for Pfizer’s respiratory syncytial virus maternal vaccine candidate for priority review

This action follows the recent acceptance of the Marketing Authorization Application (MAA) for Pfizer’s RSV vaccine candidate by the European Medicines Agency


Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Drug Approval | February 20, 2023

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States