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Exservan FDA Approval History

Last updated by Judith Stewart, BPharm on Jan 15, 2020.

FDA Approved: Yes (First approved November 22, 2019)
Brand name: Exservan
Generic name: riluzole
Dosage form: Oral Film
Company: Aquestive Therapeutics, Inc.
Treatment for: Amyotrophic Lateral Sclerosis

Exservan (riluzole) an oral film formulation of the approved glutamate Inhibitor riluzole for the treatment of patients with amyotrophic lateral sclerosis (ALS) patients who have difficulty swallowing.

  • Exservan oral film is applied to the top of the tongue where it adheres and dissolves without the need for water. Exservan is administered twice daily, at least 1 hour before or 2 hours after a meal.
  • Exservan is the third riluzole formulation to be approved by the FDA after Rilutek (oral tablet) and Tiglutik (oral suspension).
  • Common side effects of Exservan include oral hypoesthesia (numbness), asthenia (weakness), nausea, decreased lung function, hypertension, and abdominal pain.

Development Timeline for Exservan

DateArticle
Nov 25, 2019Approval  FDA Approves Exservan (riluzole) Oral Film for the Treatment of Amyotrophic Lateral Sclerosis

Further information

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