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Results For "Food-and-Drug-Administration"

1018 News Found

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).


Zydus launches Topiramate Extended-Release Capsules
Drug Approval | January 07, 2023

Zydus launches Topiramate Extended-Release Capsules

Zydus is the first company to receive final approval and launch Topiramate Extended-Release Capsules, USP 25 mg, 50 mg, and 100 mg in the United States.


InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong
Drug Approval | December 31, 2022

InnoCare get approval of Tafasitamab with Lenalidomide for the treatment of refractory diffuse large B-Cell lymphoma in Hong Kong

Tafasitamab is conditionally approved by both the U.S. Food and Drug Administration and European Medicines Agency


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


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.


Lupin receives USFDA approval for Brivaracetam Tablets
Drug Approval | December 23, 2022

Lupin receives USFDA approval for Brivaracetam Tablets


Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets
Drug Approval | December 23, 2022

Zydus receives final approval and 180 days shared exclusivity from USFDA for Selexipag Tablets

Selexipag tablet is indicated in adults for the treatment of pulmonary arterial hypertension to delay disease progression and reduce the risk of hospitalization for PAH