California-based Innovus Pharmaceuticals announced that it has signed a manufacturing agreement for its FlutiCare fluticasone propionate nasal spray in anticipation of FDA approval, which it expects in the 3rd quarter of 2016. No details were revealed. The company acquired rights to the nasal spray in February 2015; an ANDA for the OTC version had been filed by Novalere FP in November 2014. According to Innovus, over 177 million units of FlutiCare Rx have been sold since 2007.
The company said that it plans to market FlutiCare through traditional retailers in the US as well as online.
Innovus also announced that it will ask the UK MHRA for regulatory guidance prior to submitting a marketing application for the product under the Decentralized Procedure. President and CEO Bassam Damaj said, “Submitting our application to the European Agency will be another major milestone for the Company as it will open for us a very large market for our product and increase our revenues dramatically if approved.”
Read the Innovus press release on the manufacturing agreement.
Read the Innovus press release on the planned MAA.
