Zydus Cadila, a part of Cadila Healthcare (BOM: 532321), today announced it has received final approval from the US Food and Drug Administration to market a generic version of US pharma giant Pfizer’s (NYSE: PFE) KAK inhibitor Xeljanz XR (tofacitinib) extended-release tablets, 11mg and 22mg in the USA.
Zydus was the first Abbreviated New Drug Application (ANDA) filer on tofacitinib extended-release tablets 22mg and currently holds 180-day exclusivity on this strength.
Tofacitinib extended-release tablets had annual sales of around $2,082 million in the USA for the year ending June 2021 according to IQVIA data. The drug will be manufactured at the group’s formulation manufacturing facility at the SEZ, Ahmedabad.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze