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FDA Grants Orphan Drug Designation to Aquestive

For their Riluzole Oral Soluble Film

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Aquestive Therapeutics’ Riluzole Oral Soluble Film (riluzole OSF), for the treatment of amyotrophic lateral sclerosis (ALS). Riluzole OSF is currently in late-stage clinical development.   “We hope to bring riluzole OSF to ALS patients in the second half of 2019,” said Keith J. Kendall, chief executive officer of Aquestive. “Patients suffering from this debilitating neurodegenerative dise...

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