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FDA denies AstraZeneca request to block approvals of generic rosuvastatin
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The FDA has denied AstraZeneca’s citizen petition for a temporary restraining order to prevent approval of any abbreviated new drug applications for generic versions of rosuvastatin.
The company, which markets rosuvastatin under the brand name Crestor, requested a stay of approval for abbreviated new drug applications for generics until the expiration of its pediatric orphan drug exclusivity for treatment of pediatric homozygous familial hypercholesterolemia (FH), citing potential safety concerns on the grounds that “there are substantial risks that doctors would over- or undertreat pediatric [homozygous FH] patients if generic or other rosuvastatin calcium omitted AstraZeneca’s protected pediatric [homozygous FH] labeling” and that dosage and treatment courses often differ between adult and pediatric patients.
AstraZeneca in its citizen petition also argued that the “FDA lacks legal authority to carve out pediatric labeling protected by orphan drug exclusivity.”
The company also filed an injunction in federal court, which was denied.
Allergan received approval for generic rosuvastatin in May, and eight generic manufacturers have received approval since: Apote, Aurobindo, Glenmark, Mylan, Par, Sandoz, Sun and Teva.
In the FDA’s denial of the petition, the agency wrote that “Crestor’s labeling information for adults with [homozygous FH] is not ‘significantly different’ from its labeling information for pediatric patients with [homozygous FH]” and therefore does not present a safety risk.
The FDA also wrote that Section 505A(o) of the Food, Drug and Cosmetic Act does not limit the FDA’s authority to carve out the protected pediatric indication.
In 2014, AstraZeneca was given 7 years of protection for Crestor from generics under the Orphan Drug Act, but only for homozygous FH.
“While we are disappointed with this decision, we appreciate the court’s careful consideration in addressing these important issues. We are currently assessing our options and any updates will be provided in due course,” AstraZeneca spokeswoman Abigail Bozarth told Cardiology Today.
Disclosure: Bozarth is an employee of AstraZeneca.