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Results For "Zydus-Lifesciences"

195 News Found

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets
Drug Approval | February 20, 2023

Zydus receives tentative approval from USFDA for Canagliflozin and Metformin Hydrochloride Tablets

Canagliflozin and Metformin Hydrochloride Tablets had annual sales of US $49.4 million in the United States


Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg
Drug Approval | February 18, 2023

Zydus receives final approval from USFDA for Sirolimus Tablets, 1 mg and 2 mg

Sirolimus Tablets had annual sales of USD 69 million in the United States (IQVIA MAT Dec. 2022)


Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension
Drug Approval | February 16, 2023

Zydus receives tentative approval from USFDA for Bosentan tablets for oral suspension

Bosentan Tablets for Oral Suspension had annual sales of USD 16 mn in the United States (IQVIA MAT Dec. 2022)


Zydus receives tentative approval from the USFDA for Canagliflozin tablets
Drug Approval | February 16, 2023

Zydus receives tentative approval from the USFDA for Canagliflozin tablets

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya


Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules
Drug Approval | January 16, 2023

Zydus receives tentative approval from USFDA for Levomilnacipran Extended-Release Capsules

The drug will be manufactured at the group’s formulation manufacturing facility at Moraiya, Ahmedabad, India


Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets
Drug Approval | January 13, 2023

Zydus receives final approval and 180 days shared exclusivity from USFDA for Brexpiprazole tablets

Brexpiprazole is an atypical antipsychotic indicated for use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults


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).


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.


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)


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