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FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
Date:8/14/2012

s a privately held pharmaceutical company that is developing innovative nitric oxide (NO) generation and delivery platforms to enable the true potential of inhaled nitric oxide to be realized for the treatment of a multitude of diseases. The company is focused on applying its technology to delivering inhaled NO to patients in a variety of settings, including ambulatory and in-home use for potential chronic treatment.  GeNO will provide stand-alone medical devices and combination products that include the base delivery system and GeNO's nitric oxide gas.  GeNO's systems have been designated as Combination Products by the FDA Office of Combination Products, with the Division of Cardiovascular and Renal Products designated as the lead reviewer for GeNO's initial INDs. The combination products will be regulated by the FDA as new drugs with their own NDAs.Media Contacts:Carla Burigatto, 610-457-2178 Brian Heffron, 781-799-9568 cburigatto@gmail.com bheffron@ctpboston.com
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