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Harrow Health Announces FDA Acceptance of New Drug Application for AMP-100
Receives PDUFA Date of October 16, 2022 NASHVILLE, Tenn.--(BUSINESS WIRE)-- Harrow Health, Inc. (Nasdaq: HROW), an ophthalmic‑focused healthcare company,
About this update from Harrow, Inc.
[{"type":"text","content":"\nReceives PDUFA Date of October 16, 2022\n\n NASHVILLE, Tenn.--(BUSINESS WIRE)--\nHarrow Health, Inc. (Nasdaq: HROW), an ophthalmic‑focused healthcare company, today announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) filing for AMP-100, the Company’s drug candidate for ocular surface anesthesia and intraoperative pain management during ocular surgery. The FDA has assigned the application standard review and a Prescription Drug User Fee Act (PDUFA) target action date of October 16, 2022.\n\nIn commenting on the announcement, Mark L. Baum, Chief Executive Officer of Harrow Health, said, “The FDA’s acceptance of the AMP-100 NDA is a major step forward for Harrow Health Inc. and our commitment to make this patented, innovative drug candidate available. The non-opioid active pharmaceutical ingredient used in AMP‑100, if approved, would be the first approved use of this ingredient in the U.S. ophthalmic market. We look forward to working with the FDA during the review process, and we are excited about making AMP-100, if approved, commercially available to the thousands of ophthalmologists, optometrists, hospitals, and ambulatory surgery centers we serve throughout the United States.”\n\nAbout Harrow Health\n\nHarrow Health, Inc. (NASDAQ: HROW) is an ophthalmic-focused healthcare company. The Company owns and operates ImprimisRx, one of the nation’s leading ophthalmology-focused pharmaceutical businesses, and Visionology, a direct-to-consumer eye care subsidiary focused on chronic vision care. Harrow Health also holds non-controlling equity positions in Eton Pharmaceuticals, Surface Ophthalmics and Melt Pharmaceuticals, all of which started as Harrow Health subsidiaries, and owns royalty rights in four clinical‑stage drug candidates being developed by Surface Ophthalmics and Melt Pharmaceuticals. For more information about Harrow Health, please visit the Investors section of the corporate website, www.harrowinc.com.\n\nForward-Looking Statements\n\nThis press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management's current expectations and are subject...