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Results For "FDA"

1767 News Found

Zydus receives final approval from the USFDA for Febuxostat Tablets
Drug Approval | January 10, 2023

Zydus receives final approval from the USFDA for Febuxostat Tablets

Febuxostat tablets had annual sales of USD 32 million in the United States according to IQVIA data (IQVIA MAT Sept. 2022).


Lupin receives approval from USFDA for Fesoterodine Fumarate Extended-Release Tablets
Drug Approval | January 07, 2023

Lupin receives approval from USFDA for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, (RLD Toviaz®) had estimated annual sales of USD 177 million in the U.S. (IQVIA MAT September 2022).


Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets
Drug Approval | January 07, 2023

Alembic receives USFDA final approval for Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate Extended-Release Tablets, 4 mg and 8 mg, have an estimated market size of US$ 177 million for twelve months ending Sep 2022


Zydus receives final approval from USFDA for Triazolam Tablets
Drug Approval | December 31, 2022

Zydus receives final approval from USFDA for Triazolam Tablets

Triazolam tablets are used on a short-term basis to treat insomnia (difficulty falling asleep or staying asleep)


USFDA grants appeal for Ardelyx's XPHOZAH
Drug Approval | December 31, 2022

USFDA grants appeal for Ardelyx's XPHOZAH

Upon approval, XPHOZAH would be the first and only phosphate absorption inhibitor, offering patients a novel mechanism


USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents
Drug Approval | December 31, 2022

USFDA accepts for review the biologics license application for Pfizer’s Investigational MenABCWY in adolescents

If approved, the vaccine could help simplify the meningococcal vaccination schedule and provide the broadest serogroup coverage of any meningococcal vaccine


Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA
Drug Approval | December 29, 2022

Stelis Biopharma’s CDMO partner receives approval for key ANDA from the USFDA

The current approval is first of the many fillings made by the company's CDMO partners from the flagship facility in Bangalore


Mandaviya visits Safdarjung Hospital; Reviews mock drill for ensuring readiness for COVID-19 management
Healthcare | December 28, 2022

Mandaviya visits Safdarjung Hospital; Reviews mock drill for ensuring readiness for COVID-19 management

Mock drills are being conducted across the country to review the preparedness for management of COVID-19


MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes
Drug Approval | December 27, 2022

MindRank gets USFDA clearance of IND application for MDR-001 for treatment of Type 2 diabetes

MindRank expects to initiate a Phase I safety study in the first quarter of 2023.