Mylan Suit Against FDA Over Generic Heart Drug Dismissed

Mylan Inc.’s lawsuit against the U.S. Food and Drug Administration for withholding approval for the company to sell a generic version of Novartis AG’s heart pill Diovan was dismissed by a federal judge in Washington.

The FDA didn’t act “capriciously” when it denied Mylan exclusivity to market its version of Diovan, and Mylan failed to show it suffered “irreparable harm” as a result, U.S. District Court Judge John D. Bates said in an opinion filed today.

“Given Mylan’s status as a leading generic manufacturer and its already-large market presence, the potential financial impact on Mylan’s business is too small to support a finding of irreparable harm,” Bates wrote in the 25-page opinion.

In its lawsuit, Mylan had argued that a competitor, Ranbaxy Laboratories Ltd., had forfeited its right to six-month exclusivity to sell the generic drug by not winning FDA approval. Mylan asserted that the FDA’s refusal to approve its sale of the drug was arbitrary and capricious and an abuse of discretion.

On Sept. 21, Mylan, based in Canonsburg, Pennsylvania, announced a copy of Diovan HCT, a combination of the Novartis drug and hydrochlorothiazide, a diuretic, while Novartis’ own generics unit started marketing a branded version of the same drug.

Six Months

Sandy Walsh and Erica Jefferson, spokeswomen for the FDA, didn’t immediately respond to an e-mail seeking comment on the lawsuit’s dismissal. Nina Devlin, a spokeswoman for Mylan, didn’t immediately return a phone call seeking comment.

Diovan generated $5.7 billion in revenue around the world last year, according to Basel, Switzerland-based Novartis’s annual report.

Under the Hatch-Waxman Act, the company that files the first FDA application to sell a generic drug gets the right to sell it exclusively for six months if it is approved.

The case is Mylan Laboratories v. U.S. Food and Drug Administration, 12-cv-01637, U.S. District Court, District of Columbia (Washington).

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