Orphan Drug Status Sought for Ketamine as Potential ALS Therapy

Orphan Drug Status Sought for Ketamine as Potential ALS Therapy

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Orphan Drug Status Sought for Ketamine as Potential ALS Therapy

PharmaTher has filed an application with the U.S. Food and Drug Administration (FDA) requesting that ketamine be designated an orphan drug as a potential treatment of amyotrophic lateral sclerosis (ALS). Orphan drug status is granted by the FDA to encourage the development of therapies for conditions that affect fewer than 200,000 people in the U.S. Its benefits and incentives include assistance in clinical trial design, tax credits, fee waivers, and seven years of marketing exclusivity should…

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