Ketamine Earns FDA’s Orphan Drug Designation

Ketamine Earns FDA’s Orphan Drug Designation

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Ketamine Earns FDA’s Orphan Drug Designation

The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to ketamine, PharmaTher’s investigational therapy for amyotrophic lateral sclerosis (ALS). Orphan drug status is intended to encourage the development of therapies for rare diseases affecting fewer than 200,000 people in the U.S. It provides benefits and incentives, including exemption from FDA application fees, assistance in clinical trial design, and seven years of market exclusivity if eventually approved. “Receiving FDA orphan drug designation is a massive…

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