K-V Pharmaceutical Company v. United States Food and Drug Administration

MEMORANDUM OPINION

AMY BERMAN JACKSON, District Judge.

Plaintiff K-V Pharmaceutical Company (“KV”) and its wholly owned subsidiary, plaintiff Ther-RX Corporation (“TherRX”), own and market a drug called Makena, which is a hydroxyprogesterone caproate injection. Makena was approved in 2011 for use by pregnant women with a history of preterm birth to reduce the risk that they would experience another preterm birth. Plaintiffs have sued the United States Food and Drug Administration (“FDA”), its Commissioner Margaret A. Hamburg, the United States Department of Health & Human Services (“HHS”), and…