FDA Responds to AstraZeneca Exclusivity Suit

AstraZeneca’s lawsuit against the FDA over the exclusivity of one of its drugs is a “transparent” effort to stifle generic competition for the blockbuster anti-cholesterol drug Crestor, the FDA said in its response to the suit.

“This case is not about the medical needs of a small population of pediatric patients with a rare disease,” FDA argues in its response. “It is about AstraZeneca’s profit-driven desire to substantially extend its virtual monopoly on one of the world’s most popular medicines.”

AstraZeneca argued in its suit filed June 27 in U.S. District Court for the District of Columbia that generic competitors should be required to include all of Crestor’s approved indications on the label, including its exclusivity designation for pediatric homozygous familial hypercholesterolemia. That demand effectively prevents generic competition because protected indications cannot appear on competitors’ products.