U.S. FDA Grants Orphan Drug Designation (ODD) for Quilience(R) (Mazindol ER) for the Treatment of Idiopathic Hypersomnia (IH)
NLS Pharmaceutics Ltd. - Common Shares (NLSP)
Company Research
Source: Accesswire
ODD for IH in the U.S. follows July 2022 grant of ODD for treatment of IH in EuropeCurrently only 1 drug approved in the United States to treat IH while no drugs are currently approved in Europe for IHHigh unmet medical need in this rare indicationZURICH, SWITZERLAND / ACCESSWIRE / November 2, 2022 / NLS Pharmaceutics Ltd. (Nasdaq:NLSP, NLSPW) ("NLS" or the "Company"), a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system disorders, announces that it has received Orphan Drug Designation ("ODD") from the FDA in the United States for Mazindol, the active ingredient in its lead product candidate, Quilience® (Mazindol ER) for the treatment of Idiopathic Hypersomnia ("IH"). ODD is granted by the U.S. Food and Drug Administration ("FDA") to encourage the development of treatments for diseases or conditions that affect fewer than 200,000 patients in the United States. Drug pr
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NLSP
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