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 the United Kingdom.

Marketed by Italfarmaco in the United Kingdom, 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.