Allergan (AGN) Receives Positive Recommendation from EMA CHMP for OZURDEX Marketing Authorization

July 25, 2014 12:01 PM

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Allergan (NYSE: AGN) that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the Marketing Authorization for OZURDEX (dexamethasone 700 mcg intravitreal implant in applicator) to treat adult patients with vision loss due to diabetic macular edema (DME) who are pseudophakic (have an artificial lens implant), or who are considered insufficiently responsive to, or unsuitable for non-corticosteroid therapy. The CHMP is the scientific committee of the European Medicines Agency (EMA) that recommends medicines for Marketing Authorization across the 28 member states of the European Union. The final decision from the European Commission is expected within a few months.

“With a commitment to the development of innovative treatment options that address unmet patient needs, we are pleased with the CHMP’s recommendation to expand the license for OZURDEX® , an important tool in the armamentarium of the European retinal specialist, as evidenced by the fact that OZURDEX®...

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