FDA Blasts Mylan Suit Over Generic Lipitor Exclusivity

Law360, New York (April 7, 2011, 7:37 PM EDT) -- The U.S. Food and Drug Administration on Monday asked a Washington court to throw out a suit by Mylan Pharmaceuticals Inc. seeking to force the agency to strip Ranbaxy Laboratories Ltd. of the exclusive right to sell generic Lipitor, a cholesterol drug.

In a motion filed with the U.S. District Court for the District of Columbia, the FDA claims that it cannot be compelled to take any enforcement action and that Mylan has failed to establish that it will suffer irreparable injury.

India-based Ranbaxy says that...
To view the full article, register now.
Law360 Pro Say Podcast
Check out Law360's new podcast, Pro Say, which offers a weekly recap of both the biggest stories and hidden gems from the world of law.