Access Pharmaceuticals Receives 510(K) FDA Marketing Clearance for Proctigard
July 25, 2014 at 09:50 AM EDT
Dallas, TX -- (SBWIRE) -- 07/25/2014 -- ACCESS PHARMACEUTICALS, INC., a developer of new products for oncology supportive care, announced today that it has received 510(K) marketing clearance from the U.S. Food and Drug Administration (FDA) for ProctiGard™, its novel treatment for symptomatic management of rectal mucositis. The Company indicated its development of ProctiGard™ is a direct response to dialogue with the oncology community that is looking for better, more treatment options for rectal mucositis and radiation proctitis, a debilitating oncology side effect. Access believes that ProctiGard is a first-in-class treatment option that addresses a significant unmet medical need. Access currently holds global commercialization rights for ProctiGard.