Drug Approval | April 11, 2023
Zydus receives final approval from the USFDA for Azithromycin Tablets
Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States
Azithromycin Tablets USP, 500 mg had annual sales of US $20 million in the United States
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms
Acetazolamide is used to treat glaucoma
First approved therapeutic regimen that combines an anti-PD-1 and an antibody-drug conjugate in the US in these patients
NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China
Licences should enable potentially millions of people living in areas most impacted by HIV to access this innovative prevention medicine through low-cost generic manufacturers
Loperamide Hydrochloride Capsules USP, 2 mg had annual sales of US $34.7 million in the United States
Valbenazine Capsules (RLD Ingrezza) had estimated annual sales of USD 1,235 million in the U.S. (IQVIA MAT December 2022).
The company is addressing these observations
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