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Press Release: UCB to provide additional information to the U.S. FDA regarding midazolam nasal spray submission

Brussels (Belgium) & Atlanta, Georgia (U.S.) - April 1, 2019: UCB announced today that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter requesting additional information to complete the review of the New Drug Application for midazolam nasal spray, a rescue treatment for acute repetitive seizures (ARS, also known as seizure clusters) in patients with epilepsy. UCB acquired the rights to midazolam nasal spray from Proximagen in June 2018.