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
Carbidopa and Levodopa is used to treat symptoms of Parkinson's disease or Parkinson-like symptoms
Acetazolamide is used to treat glaucoma
Extends patent protection for Microbion's proprietary inhaled pravibismane for the treatment of pulmonary infections to 2039
Getinge has a strong market share in India within several product segments
The facility is over 79,000 square feet and is equipped with packaging lines
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
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
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