The US Federal Trade Commission (FTC) is requiring Impax to divest several products in order to complete a planned merger with Amneal that the companies announced in October 2017. To satisfy the FTC requirements, Impax will sell its azelastine and olopatadine nasal sprays to Perrigo, subject to completion of the merger.
Impax and Perrigo had partnered on both products. Perrigo received final approval for its azelastine nasal spray ANDA in 2014, and according to the FDA website, the company received approval for its ANDA for olopatadine nasal spray in January 2017. Perrigo filed an ANDA for a generic version of Patanase in 2011.
Impax will retain other OINDPs, including Zomig zolmitripatan nasal spray, which it acquired from AstraZeneca in 2012, and budesonide inhalation suspension and levalbuterol inhalation solution, which it acquired in 2016 when Teva was required by the FTC to divest those products prior to its acquisition of Allergan’s generics business.
Amneal’s OINDP products include azelastine and mometasone furoate nasal sprays and a generic tobramycin inhalation solution that was approved by the FDA in 2015. Amneal also signed a licensing and development deal with Iconovo for a multi-dose DPI in 2016.
Read the Impax press release.
