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Results For "Food-and-Drug-Administration"

1018 News Found

Indoco receives EIR for its Plant I manufacturing facility in Goa
Drug Approval | May 04, 2023

Indoco receives EIR for its Plant I manufacturing facility in Goa

Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.


USFDA Advisory Committee votes  n Lynparza plus Abiraterone and Prednisone  for prostate cancer
Drug Approval | May 03, 2023

USFDA Advisory Committee votes n Lynparza plus Abiraterone and Prednisone for prostate cancer

The committee voted that FDA should restrict use of LYNPARZA plus abi/pred to these BRCAm mCRPC patients


Zydus receives final approval from the USFDA for Metronidazole Topical Cream
Drug Approval | April 25, 2023

Zydus receives final approval from the USFDA for Metronidazole Topical Cream

Metronidazole is an antibiotic used on the skin to treat a certain skin disorder known as rosacea


Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules
Drug Approval | April 24, 2023

Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules

Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels


USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013
Drug Approval | April 24, 2023

USFDA lifts clinical hold on Phase 3 investigational new drug application for MaaT013

This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology


Ajinomoto Bio-Pharma receives FDA approval for high potency fill line
Drug Approval | April 22, 2023

Ajinomoto Bio-Pharma receives FDA approval for high potency fill line

Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line


Zydus receives final approval from the USFDA for Metoprolol Tartrate
Drug Approval | April 21, 2023

Zydus receives final approval from the USFDA for Metoprolol Tartrate

Metoprolol is used with or without other medications to treat high blood pressure (hypertension).


Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg
Drug Approval | April 20, 2023

Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg

Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)


Zydus receives final approval from the USFDA for Estradiol Transdermal System
Drug Approval | April 19, 2023

Zydus receives final approval from the USFDA for Estradiol Transdermal System

Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 mn in the United States


Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection
Drug Approval | April 17, 2023

Zydus receives final approval from the USFDA for Isoproterenol Hydrochloride Injection

Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output