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NEW YORK, Feb. 23, 2021 /PRNewswire/ -- Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company, today announced today the successful completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding the Company's development plan for their HT-001 product. The Pre-IND meeting was completed through written responses provided by the FDA Division of Dermatology and Dentistry on February 22, 2021.
HT-001 is a topical formulation under development for the treatment of rash and skin disorders associated with initial and repeat courses of tyrosine kinase inhibitor/epidermal growth factor receptor (EGFR) inhibitor therapy. HT-001 is being developed for New Drug Application (NDA) submission via the 505(b)(2) regulatory pathway.