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Tiglutik FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 6, 2018.

FDA Approved: Yes (First approved September 5, 2018)
Brand name: Tiglutik
Generic name: riluzole
Dosage form: Oral Suspension
Company: ITF Pharma
Treatment for: Amyotrophic Lateral Sclerosis

Tiglutik (riluzole) is an easy-to-swallow, thickened, oral suspension formulation of the approved drug riluzole for the treatment of amyotrophic lateral sclerosis (ALS).

Dosage and Administration

  • Take Tiglutik as prescribed by your healthcare provider. The recommended dose of Tiglutik is 50 mg (10 mL) taken by mouth two times each day, every 12 hours.
  • Take Tiglutik at least one hour before or two hours after a meal.
  • Take your dose using the 10 mL oral syringe that comes with Tiglutik.

Important Safety Information

  • You should not take Tiglutik if you are allergic to any of its ingredients.
  • Tiglutik can cause liver injury, including death. Your doctor should do blood tests to check your liver function before and during your treatment and may stop treatment with Tiglutik if liver function is not normal. Contact your doctor immediately if you have unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine.
  • Call your doctor immediately if you have a fever, cough, or difficulty in breathing while taking Tiglutik.
  • If you miss or skip a dose of Tiglutik, do not take any extra doses to make up for those you missed, but take your prescribed dose at the next regularly scheduled time.
  • The most common side effects of Tiglutik that occurred during medical studies were numbness/tingling around the mouth, weakness, nausea, decreased lung function, high blood pressure, and abdominal pain. If any side effects become troublesome, contact your doctor.
  • Be sure to tell your doctor and pharmacist about all other health conditions you have and all medicines you are taking, including nonprescription products and vitamins. If you have questions, please talk to your doctor.

Development timeline for Tiglutik

Sep  6, 2018Approval ITF Pharma Announces FDA Approval of Tiglutik (riluzole) Oral Suspension for the Treatment of Amyotrophic Lateral Sclerosis (ALS)

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.