Perrigo files suit to force FDA to act on 505(b)(2) issue
By Mari Serebrov
Monday, March 24, 2014
Caught in the crossfire of an innovator drug company and the sponsor of a 505(b)(2) drug, the FDA is now facing a lawsuit for not assigning a therapeutic equivalence (TE) rating to Perrigo Israel Pharmaceuticals Ltd.’s testosterone gel 1 percent, which was approved more than a year ago based on its bioequivalence to Abbvie Inc.’s Androgel.
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