Riluzole Oral Suspension (Tiglutik) Shortage: Manufacturing Issues Impact Availability

Drug Shortages medium FDA · · United States

The FDA reports a shortage of Riluzole Oral Suspension (Tiglutik) due to manufacturing interruptions, though some Teglutik presentations remain available.

What’s in Shortage

Riluzole Oral Suspension, a medication categorized for use in neurology, is currently listed in the FDA drug shortage database. This shortage affects specific presentations of the brand-name medications TEGLUTIK and TIGLUTIK. While some concentrations remain available, the 50 mg/10 mL presentation of Tiglutik is currently unavailable.

Which Manufacturers Are Affected

EDW Pharma, Inc. (formerly Italfarmaco Pharma, Inc.)

The following presentations are currently Available:

  • Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0304-1)
  • Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0305-1)
  • Teglutik, Oral Suspension, 5 mg/1 mL (NDC 70726-0306-1)

The following presentation is currently Unavailable:

  • Tiglutik, Oral Suspension, 50 mg/10 mL (NDC 70726-0303-2)

Patients or providers with questions can contact the manufacturer directly at 610-937-6172.

Why There’s a Shortage

According to the manufacturer, the shortage of the Tiglutik 50 mg/10 mL presentation is due to a product manufacturing interruption related to viscosity testing. A date for the next product release is not available at this time.

What Patients Should Do

If you are currently prescribed Riluzole Oral Suspension, please consider the following steps:

  • Consult your healthcare provider: Discuss the current availability and how it may impact your specific treatment plan.
  • Speak with your pharmacist: Inquire about the stock status of the available 5 mg/1 mL presentations.
  • Contact the manufacturer: You may call EDW Pharma, Inc. at 610-937-6172 for updates regarding supply timelines.

Disclaimer: Patients should always consult their healthcare provider or pharmacist regarding medication changes or treatment concerns.

Source

Information provided by the FDA Drug Shortage Database.
Initial Posting Date: 01/26/2024
Last Updated: 02/02/2026

Source: FDA Official Notice

Frequently Asked Questions

What is this drug shortages alert about?
The FDA reports a shortage of Riluzole Oral Suspension (Tiglutik) due to manufacturing interruptions, though some Teglutik presentations remain available.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more drug shortages alerts?
Browse all drug shortages alerts on Areazine at areazine.com/drug-shortages/ for the latest updates from FDA and other agencies.