Harrow Health Announces FDA Acceptance of New Drug Application for Ocular Pain Management
The FDA has accepted Harrow Health's new drug application (NDA) 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 target action date of October 16, 2022 under the Prescription Drug User Fee Act (PDUFA).
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.
“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," Mark L. Baum, Chief Executive Officer of Harrow Health, said in a company news release.
"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.”
About Harrow Health
Harrow Health 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.
