Harrow completes transfer of NDAs and launches 5 products in the US


In July 2023, Harrow received certain US and Canadian commercial rights for 6 branded products from Santen.

©fotofabrika / Adobe.stock.com

(Image Credit: ©fotofabrika - Adobe.Stock.com)

Harrow today announced the completion of the transfer to Harrow of the New Drug Applications (NDAs) for several products it acquired from Santen Pharmaceutical Co. Ltd.

In July 2023, Harrow received certain United States (US) and Canadian commercial rights for six branded products from Santen. Harrow completed the transfer of the NDAS for the following products:

  • FLAREX (fluorometholone acetate ophthalmic suspension) 0.1%, a corticosteroid indicated for use in the treatment of steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
  • NATACYN (natamycin ophthalmic suspension) 5%, a sterile antifungal for treating fungal blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.
  • TOBRADEX ST (tobramycin and dexamethasone ophthalmic suspension) 0.3%/0.05%, an antibiotic and corticosteroid combination for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.
  • VERKAZIA (cyclosporine ophthalmic emulsion) 0.1%, a calcineurin inhibitor immunosuppressant indicated for the treatment of vernal keratoconjunctivitis (VKC) in children and adults and holds orphan-drug exclusivity.
  • ZERVIATE (cetirizine ophthalmic solution) 0.24%, a histamine-1 (H1) receptor antagonist indicated for treating ocular itching associated with allergic conjunctivitis.

In July, Harrow announced the acquisition of the US commercial rights of these products. To date, Harrow has been receiving profit transfers on these products. However, with the transfer of the NDAs completed, Harrow has launched these products in the U.S. under the Harrow name.

Mark L. Baum, CEO of Harrow, noted the company is focused on forming commercial strategies.

“With the completion of the NDA transfer process for the branded ophthalmic portfolio that we recently acquired, our marketing and sales teams are hard at work implementing commercial strategies aimed at increasing brand awareness and sales for these products,” Baum said. “These products and others we acquired this year support a growing awareness among US eyecare professionals that Harrow is exclusively focused on and committed to serving US eyecare professionals with a full range of high-quality, accessible, and affordable products they need to care for their patients.”

Product orders for Flarex, Natacyn, Torbradex ST, Verkazia and Zerviate can be made directly through Harrow’s dedicated customer service ordering partner, Cardinal’s Cordlogistics, which includes a wholesaler distribution system encompassing McKesson and AmerisourceBergen.

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