Mylan Knocks Ranbaxy's Exclusivity Right For Valsartan

Law360, New York (October 2, 2012, 10:29 PM EDT) -- Mylan Pharmaceuticals Inc. on Tuesday hit the U.S. Food and Drug Administration with a lawsuit objecting to its award of a 180-day exclusivity period to Ranbaxy Pharmaceuticals Inc. for the marketing of a generic version of hypertension drug valsartan.

Mylan argues Ranbaxy forfeited its eligibility for the exclusivity period when it failed to obtain tentative approval of its abbreviated new drug application within 30 months after it was filed, as required by federal law. The drugmaker is asking the court to vacate the FDA's decision to...
To view the full article, register now.