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