News

Press releases and announcements

Announcement

U.S. FDA Grants Temporary Importation of TEGLUTIK (Riluzole 5 mg/mL Oral Suspension) into the United States

The U.S. Food and Drug Administration (FDA) recently granted temporary importation of TEGLUTIK (riluzole 5 mg/mL oral suspension) into the United States. To mitigate the critical and ongoing shortage of FDA-approved Tiglutik (riluzole oral suspension, 50 mg/10 mL) in the United States, the FDA recently permitted temporary importation of TEGLUTIK from Greece. Marketed by Italfarmaco … Read more

Announcement

ITF Pharma, Inc. Changes Company Name to EDW Pharma, Inc., and Relocates Corporate Headquarters

ITF Pharma, Inc. (“ITF”) has changed the company name to EDW Pharma, Inc. (“EDW”). The name change was effective November 1, 2023. EDW remains the parent company of both Womens Choice Pharmaceuticals, LLC and Edwards Pharmaceuticals, Inc. In addition, effective November 1, 2023, EDW moved the company’s corporate headquarters from Berwyn, PA to Paoli, PA. … Read more

Press Release

EDW Pharma Announces FDA Approval OF Supplemental New Drug Application (sNDA) For TIGLUTIK® (RILUZOLE) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS) with a Percutaneous Endoscopic Gastrostomy (PEG) Feeding Tube

Berwyn, Pa., Dec. 13, 2019 – EDW Pharma, a U.S.-based specialty pharmaceutical company and subsidiary of Italfarmaco, a privately-held European specialty pharmaceutical company, announced today that the U.S. Food and Drug Administration (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 (ALS).