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Biotech Stocks Facing FDA Decision In March

Jazz Pharmaceuticals
Jazz Pharmaceuticals

The FDA decision on Solriamfetol, an investigational medicine for the treatment of excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea, is now expected on March 20, 2019.

Solriamfetol, formerly known as JZP-110, is a selective dopamine and norepinephrine reuptake inhibitor.

The FDA decision on Solriamfetol was initially set for December 20, 2018, but got extended by three months following the submission of draft labeling for Solriamfetol during the course of discussions.

Jazz Pharmaceuticals acquired a license to develop and commercialize Solriamfetol from Aerial Biopharma in 2014.

The approved drugs for excessive sleepiness in adult patients with narcolepsy or obstructive sleep apnea include Modafinil and Armodafinil.

Jazz Pharma already markets a sleep drug by the name Xyrem, which is FDA-approved for excessive daytime sleepiness and cataplexy in narcolepsy for adult and pediatric patients ages 7 and older.

JAZZ closed Tuesday’s trading at $127.76, up 1.20%.