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# FDA Approves 8 Generic Crestor ANDAs After Denying Petition
- URL: https://www.fdaweb.com/fda-approves-8-generic-crestor-andas-after-denying-petition/
- Published: 2016-07-21T12:00:00.000Z
- Updated: 2026-09-14T21:16:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136247

FDA approved 7/19 eight generic copies (see approval letters below) of AstraZeneca’s cholesterol-lowering Crestor (rosuvastatin), the same day it rejected the company’s citizen petition seeking a delay on ANDA final approvals ([see earlier story](https://www.fdaweb.com/fda-denies-astrazeneca-petition-to-block-crestor-generics/)). The petition sought a block on any rosuvastatin ANDAs that contained a labeling “carve-out” omitting marketing exclusivity-protected pediatric labeling. “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. Generic approvals were granted to the following companies:

Apotex [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079145&SearchType=BasicSearch&ref=fdaweb.com)  
Mylan [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079161&SearchType=BasicSearch&ref=fdaweb.com)  
Teva [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079166&SearchType=BasicSearch&ref=fdaweb.com)  
Par [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079168&SearchType=BasicSearch&ref=fdaweb.com)  
Sun [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079169&SearchType=BasicSearch&ref=fdaweb.com)  
Aurobindo [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079170&SearchType=BasicSearch&ref=fdaweb.com)  
Sandoz [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079171&SearchType=BasicSearch&ref=fdaweb.com)  
Glenmark [Approval Letter](http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.SearchAction&searchTerm=079172&SearchType=BasicSearch&ref=fdaweb.com)