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FDA Approves Tiglutik for Treatment of ALS

ITF Pharma news release; 2018 Sep 6

ITF Pharma, headquartered in Berwyn, PA, has announced that that the US Food and Drug Administration (FDA) has approved Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). Tiglutik is the first and only easy-to-swallow thickened riluzole liquid for ALS.

Dosage/administration: Recommended dosage is 50 mg (10 mL), twice daily, taken orally via a syringe, every 12 hours. It should be taken at least 1 hour before or 2 hours after a meal. Serum aminotransferases should be measured before and during treatment.

Adverse effects: Most common adverse reactions (incidence ≥5% and >than placebo) were oral hypoesthesia, asthenia, nausea, decreased lung function, hypertension, and abdominal pain.

Citation:

ITF Pharma Announces FDA approval of Tiglutik (riluzole) oral suspension for the treatment of amyotrophic lateral sclerosis (ALS). [news release]. Berwyn, PA; ITF Pharma. September 6, 2018. https://itfpharma.com/wp-content/uploads/2018/09/FINAL-FOR-FDA-FILING_US-FDA-Approves-TIGLUTIK-Press-Release_TIGLPA092018.pdf. Accessed October 5, 2018.

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