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