AstraZeneca Sues FDA to Shield Crestor from Generic Versions

AstraZeneca PLC is seeking a U.S. court order blocking the market entry of generic forms of its best-selling drug, the cholesterol medication Crestor, which generated $5.02 billion in global sales last year, according to a complaint filed June 27 in the U.S. District Court for the District of Columbia AstraZeneca Pharmceuticals LP v. Burwellcomplaint filed.

The Food and Drug Administration this month granted the company seven years of exclusivity for Crestor as a so-called orphan drug, meaning a treatment for a rare medical condition—in this instance a form of high cholesterol in children.

But the regulator said competing cheaper ...