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K-V PHARMACEUTICAL CO. v. U.S. FOOD & DRUG ADMIN.

Civil Action No. 12-1105 (ABJ).

889 F.Supp.2d 119 (2012)

K-V PHARMACEUTICAL COMPANY, et al., Plaintiffs, v. UNITED STATES FOOD AND DRUG ADMINISTRATION, et al., Defendants.

United States District Court, District of Columbia.

September 6, 2012.

Attorney(s) appearing for the Case

Holly MacKay Conley , Michael V. Pinkel , Richard Melvyn Cooper , Williams & Connolly LLP, Washington, DC, for Plaintiff.

Gerald Cooper Kell , U.S. Department of Justice, Washington, DC, for Defendant.

MEMORANDUM OPINION

AMY BERMAN JACKSON, District Judge.

Plaintiff K-V Pharmaceutical Company ("KV") and its wholly owned subsidiary, plaintiff Ther-RX Corporation ("Ther-RX"), own and market a drug called Makena, which is a hydroxyprogestoerone 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...

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