Harrow Health, Inc. has announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) of recently acquired, FDA-approved ophthalmic medicines, IOPIDINE® 1%, MAXITROL® 3.5mg/10,000 units/0.1%, and MOXEZA® 0.5%. Harrow also announced that IOPIDINE 1% and MAXITROL are now commercially available; Harrow intends to commercialize MOXEZA 0.5% at a later date. Harrow purchased these medicines in December 2021 and has been receiving net profits from unit sales during the NDA transfer process.
“We are pleased to have completed the transfer of the NDAs for these workhorse products, allowing us to market and sell these well-known products under the Harrow umbrella,” said Mark L. Baum, CEO of Harrow Health. “We believe there is strong interest from physicians and their patients, hospitals, and ambulatory surgery centers (ASCs) in these products. The transfer of these NDAs gives Harrow a foundation to begin market access initiatives and lead conversations with commercial payer decision makers as we continue to execute our branded ophthalmic pharmaceuticals strategy.”
Product orders for IOPIDINE 1% and MAXITROL can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system that encompasses McKesson and AmerisourceBergen.
About IOPIDINE® (apraclonidine hydrochloride ophthalmic solution) 1%
IOPIDINE 1% Ophthalmic Solution contains apraclonidine hydrochloride, an alpha-adrenergic agonist, in a sterile isotonic solution for topical application to the eye. IOPIDINE 1% Ophthalmic Solution is indicated to control or prevent post-surgical elevations in intraocular pressure (IOP) that occur in patients after argon laser trabeculoplasty, argon laser iridotomy, or Nd:YAG posterior capsulotomy. IOPIDINE 1% Ophthalmic Solution is contraindicated for patients receiving monoamine oxidase inhibitor therapy and for patients with hypersensitivity to any component of this medication or to clonidine.
Read the full press release here.