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)
This plant adds around 60,000 MT of capacity, scaling Jubilant Ingrevia Limited’s overall annual Acetic Anhydride capacity to 210,000 MT
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
mRNA-4157 (V940) in combination with KEYTRUDA reduced the risk of recurrence or death by 44% compared to KEYTRUDA alone in stage III/IV melanoma patients
Study efficacy measures will include the expression of dystrophin protein and motor function.
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
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.
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