Posted by Michael Wonder on 16 Dec 2019
ITF Pharma announces FDA approval of supplemental new drug application for Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis with a percutaneous endoscopic gastronomy feeding tube
13 December 2019 - Tiglutik is the only formulation of riluzole indicated for both oral and PEG tube administration.
ITF Pharma, announced today that the U.S. FDA has approved its application to broaden the existing label for Tiglutik (riluzole) oral suspension to include administration via percutaneous endoscopic gastrostomy (PEG) tubes for the treatment of amyotrophic lateral sclerosis.
This supplemental new drug application approval expands the patient population who stand to benefit from Tiglutik to include individuals whose swallowing difficulty is complicated by alterations in nutritional status, necessitating the use of a PEG feeding tube.
