Slayback Pharma announces the final approval and launch of generic Zovirax (acyclovir) ointment 5%.
Slayback Pharma LLC announced the launch of generic Zovirax ointment (acyclovir ointment) 5%, by its out-licensee — Sandoz (Fougera). Slayback had developed the product and out-licensed the sales and marketing rights to Sandoz. The ANDA filed by Sandoz (Fougera) was approved on May 11, 2016.
The product is a generic version of Valeant’s Zovirax ointment (acyclovir ointment), which is indicated in the management of initial genital herpes and in limited non-life-threatening mucocutaneous herpes simplex virus infections in immunocompromised patients. Acyclovir ointment is contraindicated in patients who develop hypersensitivity to the components of the formulation. Acyclovir ointment is intended for cutaneous use only and should not be used in the eye.
As per the agreement between Sandoz and Slayback, terms of which remain confidential, Sandoz will continue to pay Slayback a share of the profits generated from the sale of Acyclovir ointment in the U.S.
“Slayback’s core focus is the development of complex generics primarily in parenteral and other non-solid pharmaceutical products by connecting the dots across various technologies, science, regulatory and intellectual property traditions,” Ajay K Singh, chief executive officer of Slayback Pharma, said. “The successful development and approval of a complex generic formulation of acyclovir ointment meeting FDA’s standards is a testimony to this effort.”
Slayback Pharma LLC is a specialty pharmaceutical company focused on developing, manufacturing and sourcing of complex generic pharmaceutical products, with a specific emphasis on complex injectables and other non-solid oral products.
(Source: PR Newswire)