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Results For "Zydus-Lifesciences"

195 News Found

Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg
Drug Approval | February 22, 2025

Zydus receives final approval from USFDA for Ibuprofen and Famotidine Tablets, 800 mg/26.6 mg

Ibuprofen and famotidine combination is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis


Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS
Drug Approval | January 23, 2025

Zydus announces USFDA Orphan Drug Designation to Usnoflast for treatment of ALS

The company is committed to unlocking new frontiers in neuroscience and developing Usnoflast for patients with ALS


Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease
Drug Approval | January 07, 2025

Sentynl Therapeutics receives USFDA acceptance and priority review of new drug application for CUTX-101 product candidate for treatment of Menkes disease

Menkes disease is a rare X-linked recessive pediatric disease caused by gene mutations of the copper transporter ATP7A


Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary
News | January 07, 2025

Zydus inks agreement with CVS Caremark to add Zituvio, Zituvimet and Zituvimet XR to its template formulary

These three NDAs of Sitagliptin (base) and combination franchise have been approved by the USFDA earlier through the 505(b)(2) route


Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP
Drug Approval | December 20, 2024

Zydus receives final approval from USFDA for Lidocaine and Prilocaine Cream USP

Lidocaine and Prilocaine cream had annual sales of US $22.05 million in the United States (IQVIA MAT October 2024)


Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV
Drug Approval | October 23, 2024

Zydus receives acceptability from WHO for Typhoid Vi Conjugate Vaccine ZyVac TCV

Company receives acceptability, in principle, for ZyVac TCV making it eligible for purchase by United Nations procurement agencies


Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg
Drug Approval | October 19, 2024

Zydus receives final approval from USFDA for Fludrocortisone Acetate Tablets USP, 0.1 mg

Fludrocortisone acetate tablets will be produced at the Group's manufacturing site at Moraiya, Ahmedabad


Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease
News | October 14, 2024

Zydus and ICMR initiate a Phase 2 trial of Desidustat in patients with Sickle Cell Disease

The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease


Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg
Drug Approval | October 11, 2024

Zydus receives final approval from USFDA for Paliperidone ER Tablets, 1.5 mg, 3 mg, 6 mg, and 9 mg

Paliperidone extended-release tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad


Zydus receives tentative approval from USFDA for Enzalutamide Tablets
Drug Approval | October 02, 2024

Zydus receives tentative approval from USFDA for Enzalutamide Tablets

Enzalutamide Tablets will be produced at the Group’s manufacturing site at SEZ, Ahmedabad