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Results For "Food-and-Drug-Administration"

1174 News Found

Zydus receives final approval from USFDA for Esomeprazole Magnesium
Drug Approval | June 09, 2023

Zydus receives final approval from USFDA for Esomeprazole Magnesium

Esomeprazole Magnesium for Delayed-Release Oral Suspension, 20 mg and 40 mg had annual sales of USD 42 mn in the United States (IQVIA MAT April 2023)


Zydus receives final approval from the USFDA for Tadalafil Tablets USP
Drug Approval | June 08, 2023

Zydus receives final approval from the USFDA for Tadalafil Tablets USP

Tadalafil Tablets USP, 20 mg had annual sales of USD 61 mn in the United States (IQVIA MAT April 2023)


European Commission authorises GSK’s Arexvy for older adults
Drug Approval | June 08, 2023

European Commission authorises GSK’s Arexvy for older adults

Authorisation will help protect adults 60 years of age and older in 30 European countries* from RSV disease for the first time


USFDA approves Injectafer for the treatment of iron deficiency in adult patients with heart failure
Drug Approval | June 06, 2023

USFDA approves Injectafer for the treatment of iron deficiency in adult patients with heart failure

Injectafer is now the first and only intravenous (IV) iron replacement therapy indicated for adult patients with heart failure who have iron deficiency


Novartis receives European approval for Cosentyx
Drug Approval | June 03, 2023

Novartis receives European approval for Cosentyx

European approval is based on robust Phase III data showing Cosentyx provided rapid symptom relief from as early as Week 4, with response rates continuing to improve up to 1 year1,3-5


Lupin receives USFDA approval from Obeticholic Acid Tablets
Drug Approval | June 01, 2023

Lupin receives USFDA approval from Obeticholic Acid Tablets

Obeticholic Acid Tablets had estimated annual sales of US$ 262 million in the U.S. (IQVIA MAT Mar 2023).


Concept Medical gets 4th IDE approval from USFDA
Drug Approval | May 31, 2023

Concept Medical gets 4th IDE approval from USFDA

For the treatment of Superficial Femoral Artery


Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection
Drug Approval | May 22, 2023

Zydus receives final approval from the USFDA for Ephedrine Sulfate Injection

Ephedrine Sulfate Injection USP, 50 mg/mL had annual sales of USD 52 mn in the United States


Strides Puducherry facility receives EIR  from USFDA
Drug Approval | May 20, 2023

Strides Puducherry facility receives EIR from USFDA

The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.


Hikal announces USFDA audit with zero observations
Drug Approval | May 16, 2023

Hikal announces USFDA audit with zero observations

This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites