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Results For "Zydus-Worldwide-DMCC"

6 News Found

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market
Drug Approval | January 19, 2024

Zydus and Synthon inks licensing and supply agreement for Palbociclib Tablets for US market

Synthon will be responsible for obtaining US regulatory approval for Palbociclib Tablets


Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US
News | December 12, 2023

Zydus inks licensing agreement with Daewoong Pharmaceutical for leuprolide injectable in the US

The exclusive agreement also includes development, regulatory, and commercialization milestone payments based on the successful outcome


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 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


Zydus receives tentative approval from USFDA for Valbenazine capsules
Drug Approval | October 18, 2022

Zydus receives tentative approval from USFDA for Valbenazine capsules

Valbenazine Capsules had annual sales of US $781 million in the United States according to IQVIA data


Zydus receives final approval from the USFDA for Efinaconazole Topical Solution
Drug Approval | July 18, 2022

Zydus receives final approval from the USFDA for Efinaconazole Topical Solution

Jublia (Efinaconazole) topical solution, 10% had annual sales of $292 million in the United States according to IQVIA data (IQVIA MAT May 2022).