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# AstraZeneca Sues FDA Over Pediatric ‘Carve Outs’
- URL: https://www.fdaweb.com/astrazeneca-sues-fda-over-pediatric-carve-outs/
- Published: 2016-06-28T12:00:00.000Z
- Updated: 2026-09-14T21:12:14.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136062

AstraZeneca filed suit 6/27 in DC federal court challenging FDA’s interpretation of statutes and regulations that (i) prohibit a generic drug from being marketed unless it includes all pediatric information appearing on the corresponding brand-name drug label, and (ii) allow generic drug manufacturers to “carve out” or omit certain labeling for which the brand-name drug manufacturer has marketing exclusivity. At issue, is the upcoming approval of 10 generic applications for a copies of the company’s blockbuster cholesterol-lowering Crestor (rosuvastatin calcium), with approval coming as early as 7/8 for some of the submissions.

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.

AstraZeneca also argues that in 2015 the agency began interpreting statutes and regulations in a way that broadens generic drug manufacturers’ ability to carve out pediatric labeling in situations where the brand-name manufacturer has exclusive marketing rights. This interpretation, according to AstraZeneca, can be found in a [4/2015 letter](http://www.fda.gov/downloads/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/abbreviatednewdrugapplicationandagenerics/ucm444858.pdf?ref=fdaweb.com) to Otsuka. “FDA’s 2015 interpretation is unlawful,” the company says. “FDA’s pediatric-labeling regulations impose a categorical rule: A generic drug must include all pediatric labeling approved for the corresponding brand-name drug. Although Congress has enacted a handful of narrow and carefully targeted exceptions to that categorical rule, none of those exceptions (also known as carve out authorities) provides a valid basis for FDA’s 2015 Interpretation.”