Perrigo
This article was originally published in The Tan Sheet
Executive Summary
Two ANDA approvals expected "very shortly," with six to eight additional approvals likely in 12-15 months following private labeler's resolution of quality control problems cited in August warning letter, President & CEO David Gibbons says at UBS Warburg Global Specialty Pharmaceuticals Conference May 23. "We have recently been notified by the FDA that we have satisfactorily addressed the issues...and we are now able to get our ANDAs approved," Gibbons says. Perrigo has nine ANDAs pending with the agency; firm is eyeing near-term launches of private label Pepcid AC, Advil Cold & Sinus, Rogaine Extra Strength, Excedrin Migraine and NasalCrom