Zydus receives final FDA approval for new strengths of generic Xeljanz
Zydus Lifesciences (NYSE: ZYDUSLIFE) today revealed it has received final approval for Tofacitinib Tablets, 5mg and tentative approval for Tofacitinib Tablets, 10mg, generic versions of US pharma giant Pfizer’s (NYSE: PFE) Xeljanz from the US Food and Drug Administration (FDA).
Zydus was one of the first abbreviated new drug applications (ANDA) to submit a substantially complete ANDA with a paragraph IV certification for Tofacitinib Tablets, 5mg and therefore is eligible for 180 days of shared generic drug exclusivity for the generic. Zydus gained180-exclusivity for tofacitinib extended-release tablets, 11mg and 22mg in the USA in 2021.
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
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
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
More on this story...
Today's issue
Company Spotlight
More Features in Generics
| Headless Content Management with Blaze