3 Things Could Make Or Break An ANDA

Law360, New York (May 1, 2008, 12:00 AM EDT) -- Here are the top three factors that generics drugmakers should take into account when preparing to submit an abbreviated new drug application with the U.S. Food and Drug Administration.

How carefully companies consider these factors and which decisions they make at this stage can ultimately affect their approach to litigation — and how successful the lawsuit is, experts say.

One: Am I going to be sued?

Prior to making any other move in preparing to fight for the right to market a generic medication, a generic...
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