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# Orange Book Has Crestor Exclusivity Error: AZ
- URL: https://www.fdaweb.com/orange-book-has-crestor-exclusivity-error-az/
- Published: 2016-06-28T12:00:00.000Z
- Updated: 2026-09-14T21:12:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136061

AstraZeneca is [asking](https://www.regulations.gov/contentStreamer?documentId=FDA-2016-P-1485-0005&attachmentNumber=1&disposition=attachment&contentType=pdf&ref=fdaweb.com) FDA to correct an exclusivity error for its Crestor in the latest *Orange Book* update. The letter references a 5/31/16 petition that asked the agency not to approve any ANDA or 505(b)(2) application referencing Crestor (rosuvastatin calcium) until expiration of the orphan drug exclusivity for its use in treating pediatric patients ages 7 to 17 with homozygous familial hypercholesterolemia (HoFH). It says the orphan drug exclusivity for pediatric HoFH was based on FDA’s 5/27/16 approval of a Crestor sNDA.

Following approval of the sNDA and the agency’s resulting update to the *Orange Book*, the company wrote to FDA to ask it to correct the exclusivity period. That letter said the *Orange Book* shows a new three-year period of new indication exclusivity running to 5/27/19\. “This entry is in error,” AstraZeneca said. “That exclusivity period does not apply and should be removed from the *Orange Book*.”

The company maintains that the only claim for exclusivity it submitted was for seven years of orphan drug exclusivity, and not for exclusivity under any other provision. “Accordingly…,” it says, “no such three-year exclusivity period applies and none should be granted. The only new period of exclusivity that applies and should remain in the *Orange Book* is the period of orphan drug exclusivity running to 5/27/23.