Drug Approval | September 19, 2024
Lupin receives USFDA approval for Bumetanide Injection
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
Bumetanide Injection USP (RLD Bumex) had estimated annual sales of USD 20 million in the U.S.
New indication supported by the MANDARA trial which showed nearly 60% of patients achieved remission and 41% of patients fully stopped taking oral corticosteroids
He has been associated with Caplin Steriles Ltd., Mylan Laboratories Ltd., Caplin Point Laboratories Ltd., Strides Arcolab Ltd. and Novartis Vaccines and Diagnostics
This validation aligns with Piramal Pharma's core purpose of 'Doing Well and Doing Good,'
Fluoxetine Tabs 60 mg approval solidifies the company's position in the molecule by complementing the recent approval in April 2024 for Fluoxetine 10 mg and 20 mg tablets and Fluoxetine capsules
Both the products are Gadolinium based Magnetic Resonance Imaging (MRI) contrast agents and will be the first set of contrast agent products in Zydus’ injectable portfolio for the US market
Chobhe brings over 30 years of extensive experience in quality and regulatory management within the pharmaceutical industry
Finerenone is the first mineralocorticoid receptor (MR) antagonist to demonstrate definitive cardiovascular benefits in a Phase III study in patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ?40%
The company is making its mark through strategic initiatives, promising to become a significant presence in the evolving pharmaceutical sector
First patient enrolled in the Phase III SOHO-02 trial of investigational agent BAY 2927088 in treatment-naïve patients with advanced NSCLC with HER2-activating mutations
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