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BioWorld - Tuesday, February 24, 2026
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Home » Perrigo files suit to force FDA to act on 505(b)(2) issue
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Perrigo files suit to force FDA to act on 505(b)(2) issue

March 25, 2014
By Mari Serebrov
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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