
The US Food and Drug Administration has accepted a supplemental new drug application (sNDA) and granted Priority Review for Anglo-Swedish pharma major AstraZeneca’s (LSE: AZN) Brilinta (ticagrelor) tablets for patients with a history of heart attack.
A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015. In its current indications, Brilinta generated first-quarter 2015 sales of $131 million, up 32% year-on-year.
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
| Headless Content Management with Blaze