Drug Approval | 24 April 2023
Zydus receives final approval from the USFDA for Icosapent Ethyl Capsules
Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels
Icosapent Ethyl Capsules are indicated as an adjunct to diet to reduce triglyceride levels
The USFDA had classified the inspection as "Official Action Indicated" (OAI).
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
Aji Bio-Pharma has six fill finish lines located in San Diego, including a new line
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
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.
Envelta is the company’s non-opioid pain product candidate for acute and chronic pain
Designation based on positive data from Phase 2b KEYNOTE-942/mRNA-4157-P201 trial and unmet need for additional therapeutic options for certain types of melanoma
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
Brimonidine Tartrate Ophthalmic Solution is an alpha adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure
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