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Results For "Food-and-Drug-Administration"

1018 News Found

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules
Drug Approval | December 02, 2022

Zydus receives final approval from USFDA for Topiramate Extended-Release capsules

Topiramate Extended-Release capsule had annual sales of US $68.8 mn in the United States according to IQVIA data (IQVIA MAT Sep 2022)


Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)
Drug Approval | November 30, 2022

Cipla launches Leuprolide Acetate Injection Depot ( (22.5 mg)

Leuprolide Acetate Injection Depot contains 22.5 mg of leuprolide acetate for 3- month administration given as a single dose injection.


Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection
Drug Approval | November 29, 2022

Zydus receives tentative approval from USFDA for Levothyroxine Sodium for Injection

The drug will be manufactured at the group's injectable manufacturing facility at Jarod, near Vadodara, India


Briefs: IOL Chemicals and Cipla
News | November 27, 2022

Briefs: IOL Chemicals and Cipla

Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".


Zydus receives final approval from USFDA for Famotidine Injection
News | November 24, 2022

Zydus receives final approval from USFDA for Famotidine Injection

Famotidine Injection is indicated to treat ulcers of the stomach and intestines and to prevent intestinal ulcers from coming back after they have healed


USFDA grants priority review of BLA for dengue vaccine TAK-003
Drug Approval | November 23, 2022

USFDA grants priority review of BLA for dengue vaccine TAK-003

If approved, TAK-003 has the potential to become an important dengue prevention option for healthcare providers


Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster
Diagnostic Center | November 21, 2022

Pfizer and BioNTech report new data on Omicron BA.4/BA.5-adapted bivalent booster

Omicron BA.5 continues to be the most prevalent sublineage in the United States (nearly 30% of cases) at the time of publication of the data


USFDA completes pre-approval inspection of BHL's Vadodara facility
Drug Approval | November 21, 2022

USFDA completes pre-approval inspection of BHL's Vadodara facility

The pre-approval inspection of USFDA was completed successfully with ZERO 483 observation of the manufacturing facilities of Bajaj Healthcare Limited


Aurobindo Pharma receives 10 observations for Unit IX
Drug Approval | November 21, 2022

Aurobindo Pharma receives 10 observations for Unit IX

The company had responded to the agency and carried out the required corrective actions.


Biocon Biologics features on ASIA IP ELITE List 2022
News | November 14, 2022

Biocon Biologics features on ASIA IP ELITE List 2022

This is the fifth consecutive year that a Biocon Group company has made it to the Asia lP ELITE list