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K-V Pharmaceutical Loses FDA Lawsuit Over Makena Drug

K-V Pharmaceutical Co.’s lawsuit alleging that the U.S. Food and Drug Administration’s actions led to “unlawful competition” involving its Makena drug was dismissed by a federal judge.

U.S. District Judge Amy Berman Jackson in Washington today threw out the company’s claims that the FDA caused it “irreparable harm” by refusing to block pharmacies that created a cheaper alternative of the drug used to reduce the risk of pre-term birth in women.

“This case is fundamentally an effort to get the court to direct and oversee the FDA’s enforcement activities, and that it cannot do,” Jackson said in her 38-page ruling.

The lawsuit, filed July 5, alleges that K-V is “almost entirely reliant” on the success of Makena for the money it needs to finance the company’s operations and make debt payments, according to the ruling.

K-V, based in Bridgeton, Missouri, filed for Chapter 11 protection in U.S. Bankruptcy Court in Manhattan on Aug. 6. The company, which owes secured lenders $235 million, told a judge at a court hearing the next day that its value depends on the outcome of the FDA lawsuit and continued protection from competitors. Presuming such protection, K-V last year projected Makena revenue of more than $400 million by 2013.

Georgia Ruling

Makena, an injectable drug, was approved by the FDA in 2011 for use by pregnant women with a history of pre-term birth.

Tony Herrling, a spokesman for K-V, said the company received a favorable court ruling in Georgia requiring that the state’s Medicaid agency cover FDA-approved drugs and reimburse for Makena.

“The central issue for K-V Pharmaceutical, in its several court actions regarding MakenaR, has always been to ensure that pregnant women have access to MakenaR, the only drug approved by the Food and Drug Administration for their condition,” Herrling said in an e-mailed statement.

The case is K-V Pharmaceutical Co. v. U.S. Food and Drug Administration, 12-cv-01105, U.S. District Court, District of Columbia (Washington).

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