Drug Approval | April 20, 2023
Zydus receives final approval from USFDA for Roflumilast Tablets, 250 mcg
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD)
Estradiol Transdermal System USP, 0.014 mg/day (weekly) had annual sales of USD 1.9 mn in the United States
Isoproterenol hydrochloride injection is indicated to improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output
Acceptance based on results from the Phase 3 KEYNOTE-859 trial, which showed significant overall survival benefit in these patients with HER2-negative disease, regardless of PD-L1 expression
Tavaborole Topical Solution, 5% had annual sales of US $3.1 million in the United States
Collaboration will enable rapid advancement of a joint preclinical proof of concept program for type 1 diabetes
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
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