Drug Approval | April 24, 2023
USFDA suggests corrective measures to Sun Pharmaceutical’s Mohali facility
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
Metoprolol is used with or without other medications to treat high blood pressure (hypertension).
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
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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