AstraZeneca asks FDA to delay ANDAs for Crestor generics
AstraZeneca has filed a citizen petition to the US Food and Drug Administration (FDA) requesting it to wait until 2023 before approving generic versions of Crestor (rosuvastatin calcium), a cholesterol treatment.
If you don't have a login or your access has expired, you will need to purchase a subscription to gain access to this article, including all our online content.
For more information on individual annual subscriptions for full paid access and corporate subscription options please contact us.
To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.
For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk
1 April 2026 After years of strict patent rules, Argentina is changing course. New IP reforms are putting the country back on the map, but how companies handle the transition will matter.
19 March 2026 Although the court agreed that the tech giant misappropriated some of Masimo’s information related to pulse oximetry technology, Apple is not barred from using it, says a California judge.