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# FDA Denies AstraZeneca Petition to Block Crestor Generics
- URL: https://www.fdaweb.com/fda-denies-astrazeneca-petition-to-block-crestor-generics/
- Published: 2016-07-20T12:00:00.000Z
- Updated: 2026-09-14T21:16:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136238

FDA has [denied](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1485-0007&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) an AstraZeneca citizen petition seeking to block the approval of generic copies of its blockbuster cholesterol-lowering Crestor (rosuvastatin calcium) if they are considered with a labeling “carve-out” that omits marketing exclusivity-protected pediatric labeling. The company also lost its bid to gain a temporary restraining order ([see earlier sto](https://www.fdaweb.com/astrazeneca-seeks-block-on-fda-generic-crestor-decisions/)ry) from the DC District Court, which sided with FDA’s decision. The agency now has begun approving ANDAs that were previously tentatively approved.

AstraZeneca had argued ([see complaint](http://www.fdaweb.com/download.php?file=4765567-0--7400.pdf)) that it currently has orphan drug marketing exclusivity for Crestor’s use in treating a rare and serious pediatric “orphan” disease known as homozygous familial hypercholesterolemia (HoFH). The orphan drug exclusivity, it said, should preclude FDA from granting final approval for generic rosuvastatin applications until 5/2023.

“FDA does not believe that carving out the orphan-protected pediatric HoFH indication would present a safety risk to pediatric patients with HoFH and concludes that a 505(b)(2) NDA or ANDA referencing Crestor that does not include the orphan-protected information in its labeling is safe and effective for the remaining non-protected conditions of use,” the agency said in its denial letter. “As a scientific matter, FDA concludes that Crestor’s labeling information for adults with HoFH is not significantly different from its labeling for pediatric patients with HoFH.“

FDA also pointed out that the adult HoFH indication has been included in Crestor’s label since it was first approved in 2003\. “To the extent that Crestor was used in pediatric patients with HoFH before the pediatric HoFH indication was added to Crestor’s labeling in 5/2016, there have been no reports to the FDA Adverse Event Reporting System to indicate there is any new or increased severity of any safety issue with the use of crestor by pediatric patients,” it said.