Drug Court
The U.S. District Court for the District of Columbia ruled against Mylan last month in the generic company's claim that the FDA improperly had withdrawn final approval of Mylan's abbreviated new drug application for its fentanyl transdermal patchJames Frederick The U.S. District Court for the District of Columbia ruled against Mylan last month in the generic company's claim that the FDA improperly had withdrawn final approval of Mylan's abbreviated new drug application for its fentanyl transdermal patch, which is equivalent to Janssen Pharmaceutica's Duragesic patch.
"We are disappointed with the ruling because we continue to believe that the FDA acted contrary to several sections of the Food, Drug and Cosmetic Act, the Administrative Procedures Act, FDA's regulations and legal precedent," said Robert Coury, Mylan's vice chairman and chief executive officer.
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