BREAKING NEWS: Zydus Cadila Gets US Approval To Market Roflumilast Tablets - medtigo



BREAKING NEWS: Zydus Cadila Gets US Approval To Market Roflumilast Tablets

Share on facebook
Share on twitter
Share on linkedin
Share on whatsapp

Cadila Healthcare Ltd announced on Monday that its subsidiary Zydus Pharmaceuticals (USA) Inc had received final permission from the US Food and Drug Administration to market its generic version of Roflumilast tablets in the strength of 500 mcg, which is used to lower the risk of COPD exacerbations.

Cadila Healthcare said in a regulatory filing that Zydus, as one of the first applicants for Roflumilast Tablets, 500 mcg, is entitled to 180 days of shared generic medication exclusivity.

According to the company, the US Food and Drug Administration (USFDA) has also given Roflumilast tablets, 250 mcg, a provisional approval.

The drug will be made at the group’s formulation manufacturing facility in Ahmedabad’s Special Economic Zone.

According to the company, roflumilast tablets are used to lower the risk of COPD exacerbations in patients with severe COPD, chronic bronchitis, and a history of exacerbations.

Since the filing procedure in FY 2003-04, the group has received 327 approvals and filed over 400 abbreviated new drug applications (ANDAs).

Leave a Reply


Free CME credits

Both our subscription plans include Free CME/CPD AMA PRA Category 1 credits.

Digital Certificate PDF

On course completion, you will receive a full-sized presentation quality digital certificate.

medtigo Simulation

A dynamic medical simulation platform designed to train healthcare professionals and students to effectively run code situations through an immersive hands-on experience in a live, interactive 3D environment.

medtigo Points

medtigo points is our unique point redemption system created to award users for interacting on our site. These points can be redeemed for special discounts on the medtigo marketplace as well as towards the membership cost itself.
  • Registration with medtigo = 10 points
  • 1 visit to medtigo’s website = 1 point
  • Interacting with medtigo posts (through comments/clinical cases etc.) = 5 points
  • Attempting a game = 1 point
  • Community Forum post/reply = 5 points

    *Redemption of points can occur only through the medtigo marketplace, courses, or simulation system. Money will not be credited to your bank account. 10 points = $1.

All Your Certificates in One Place

When you have your licenses, certificates and CMEs in one place, it's easier to track your career growth. You can easily share these with hospitals as well, using your medtigo app.

Our Certificate Courses