U.S. FDA nod for Aurobindo’s Droxidopa capsules

Drugmaker Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (US FDA) to manufacture and market Droxidopa capsules, 100 mg, 200 mg and 300 mg.

Droxidopa Capsules are generic version of Lundbeck NA’s Northera capsules and will be launched immediately, the company said on Friday. The approved product has an estimated market size of $352 million for the 12 months ending December 2020, a release said quoting IQVIA numbers.

Droxidopa is indicated for the treatment of orthostatic dizziness and lightheadedness in adult patients with symptomatic neurogenic orthostatic hypotension caused by primary autonomic failure, dopamine beta-hydroxylase deficiency and non-diabetic autonomic neuropathy.

The release said this is the 24th ANDA to be approved out of Unit-X formulation facility in Hyderabad, used for manufacturing oral products. Aurobindo has a total of 469 ANDA approvals (440 final approvals and 29 tentative approvals) from U.S. FDA.

You have reached your limit for free articles this month.

Subscription Benefits Include

Today’s Paper

Find mobile-friendly version of articles from the day’s newspaper in one easy-to-read list.

Unlimited Access

Enjoy reading as many articles as you wish without any limitations.

Personalised recommendations

A select list of articles that match your interests and tastes.

Faster pages

Move smoothly between articles as our pages load instantly.


A one-stop-shop for seeing the latest updates, and managing your preferences.


We brief you on the latest and most important developments, three times a day.

Support Quality Journalism.

*Our Digital Subscription plans do not currently include the e-paper, crossword and print.


Source link

Leave a Reply

Your email address will not be published. Required fields are marked *

This site uses Akismet to reduce spam. Learn how your comment data is processed.