Sebra /
30 June 2016Americas

AstraZeneca sues FDA over cholesterol drug

AstraZeneca has sued the US Food and Drug Administration (FDA), asking a court to prevent the FDA from approving any generic version of Crestor (rosuvastatin), which is due to expire on July 8 this year.

The company is requesting the court to order the FDA to not approve generic versions of the cholesterol drug until May 27, 2023, claiming that it is entitled to seven years’ orphan drug exclusivity period under the Orphan Drug Act of 1983.

The suit centring on the drug, which lowers triglycerides in the blood to slow down the build-up of plaque in blood vessels, was filed in the US District Court for the District of Columbia on Monday, June 27.

The FDA is in a position where it could approve generics of Crestor as soon as July 8, which may threaten AstraZeneca financially.

The complaint said: “Additional generic manufacturers would immediately flood the market with low-cost rosuvastatin calcium—thereby dramatically eroding Crestor’s market share and causing AstraZeneca to sustain substantial and immediate revenue losses.”

Several companies are waiting approval of Abbreviated New Drug Applications for a generic Crestor, prompting AstraZeneca to further ask the court to expedite proceedings.

The Orphan Drug Act 1983 allows the FDA to award an additional seven years of marketing exclusivity to reward companies for developing drugs to treat rare conditions and diseases. Rare or “orphan” diseases are defined as those that affect 200,000 or fewer Americans.

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