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# AstraZeneca Seeks Block on FDA Generic Crestor Decisions
- URL: https://www.fdaweb.com/astrazeneca-seeks-block-on-fda-generic-crestor-decisions/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:36.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136125

AstraZeneca has filed a motion seeking a temporary restraining order (TRO) to block FDA from approving generic copies of the company’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium) if they are approved with a labeling “carve-out” that omits marketing exclusivity-protected pediatric labeling. The TRO request follows last month’s complaint ([see story](https://www.fdaweb.com/astrazeneca-sues-fda-over-pediatric-carve-outs/)) in DC federal court challenging the agency’s 2015 interpretation of statutes and regulations permitting approval of a generic drug that omitted such protected labeling. During a hearing 7/7, FDA reportedly told the court that approval decisions on the pending ANDAs could come this week.

AstraZeneca argues ([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 says, should preclude FDA from granting final approval for generic rosuvastatin applications until 5/2023.

In response to the TRO request, FDA says the matter is unripe for judicial review because it has not issued any final approval order for any of the pending generics. “Courts in this district and elsewhere have repeatedly rejected these challenges, however, and have routinely rebuffed bids by brand name companies to obtain pre-approval review of anticipated FDA action on generic applications before the applications are even approved,” the agency says in its [motion ](http://www.fdaweb.com/download.php?file=FDAMotion.pdf)objecting to a TRO. Additionally, FDA says it would be premature for the court to interfere while a citizen petition from AstraZeneca raising the same arguments is pending before the agency. FDA further argues that the statute precludes courts from taking any action before a ruling has been made on a petition because, as such, plaintiffs have not yet exhausted their administrative remedies.