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Mylan Sues FDA for Approval of Generic Version of Diovan

Mylan Inc. sued the U.S. Food and Drug Administration for approval to sell a generic version of Novartis AG’s heart pill Diovan after a competitor failed to get the drug on the market in time.

Mylan, in a lawsuit filed today in federal court in Washington, said Ranbaxy Laboratories Ltd. forfeited its right to six-month exclusivity to sell the generic drug by not winning FDA approval. Mylan argues the FDA’s refusal to approve its sale of the drug is arbitrary and capricious and an abuse of discretion.

“Ranbaxy failed to receive tentative approval prior to the statutory 30-month forfeiture deadline, and no statutory exception to forfeiture applies,” Mylan said in its complaint.

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.

Sandy Walsh, an FDA spokeswoman, said the agency doesn’t comment on pending litigation.

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

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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