Post

2 Drugs from India’s Zydus win USFDA Approval

2 Drugs from India’s Zydus win USFDA Approval

Zydus Lifesciences  has received tentative approval from the FDA to market its Amantadine Extended-Release Capsules  in the United States. Amantadine is indicated for the treatment of dyskinesia (sudden uncontrolled movements) in patients with Parkinsons disease who are treated with levodopa therapy, with or without dopaminergic medicines. The pharmaceutical company said that the drug will be manufactured at the groups formulation manufacturing facility at Ahmedabad Special Economic Zone, in India’s western state of Gujarat.

Amantadine Extended-Release Capsules had annual sales of $2.7 million in the United States according to IQVIA data (IQVIA MAT Aug 2022).

pills

In other news, the company also won FDA approval to market Brivaracetam tablets. Brivaracetam is indicated for the treatment of partial-onset seizures in patients 4 years of age and older. The drug will be manufactured at Ahmedabad SEZ, India. Brivaracetam Tablets had annual sales of $412 million in the United States according to IQVIA data.

Share

About Amritt

Who We Are

Small or big, your business will love our financial help and business consultations! We are happy when our clients are too… Actually, this is quite simple to achieve – because each time we help them in sorting out different accounting intricacies or save the day before filing the taxes, they are happy indeed! And so are we.   

We have over Twenty years of experience helping our clients succeed in India

Generic selectors
Exact matches only
Search in title
Search in content
Post Type Selectors
Blog
Page
Dictionary
Comparisons
Capabilities
India Business Guide
Services
Private
Speaking
Insights
White Papers
News
Newsletters
Clients
Case Studies
Companies In India
Webinars
Presentations
Industries