Mylan generic heart drug suit against FDA dismissed

WASHINGTON — A federal judge in Washington has dismissed a suit against the FDA brought up by Mylan for withholding approval for the company to sell a generic version of Novartis AG’s heart pill, Diovan.

U.S. District Court Judge John D. Bates said in an opinion filed on Dec. 27, that the FDA did not act “capriciously” when it denied Mylan exclusivity to market its version of Diovan. Bates also said Mylan did not show it suffered “irreparable harm” as a result.

“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.

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

Mylan, based in Canonsburg, Pa., announced a copy of Diovan HCT on Sept. 21. The generic version is a combination of the Novartis drug and hydrochlorothiazide, a diuretic. At the time, Novartis began marketing a branded version of the drug through its generics unit.