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 in Greece, TEGLUTIK is manufactured in Spain. The safety profiles of the FDA-approved Tiglutik and the imported TEGLUTIK products are comparable, and no safety concerns emerged from the comparison of the two products.
Please visit the FDA-approved Tiglutik website (www.tiglutik.com) for a copy of the Dear Healthcare Provider letter (DHCP) related to the temporary importation. In addition, healthcare providers and patients can also access the side-by-side comparisons, in English, between the U.S. product information and the European product information on the Tiglutik website.