Florida Pharmaceutical Products, Inc., Files ANDA With FDA
BOCA RATON, Fla. and COIMBRA, Portugal, Jan. 14, 2019
BOCA RATON, Fla. and COIMBRA, Portugal, Jan. 14, 2019 /PRNewswire-PRWeb/ -- Florida Pharmaceutical Products, Inc., also known as 'FPP' (http://www.flpharmaproducts.com) and Bluepharma Indústria Farmacêutica, S.A. (http://www.bluepharmagroup.com), two pharmaceutical companies involved in development, sales, marketing and distribution of generic pharmaceuticals are pleased to announce the signing of an agreement for development and licensing of an ANDA to file with the U.S. Food and Drug Administration (FDA).
The submission is for approval of a selective serotonin reuptake inhibitor (SSRI). The product has current sales of $50 million according to IQVIA™ and benefits from limited competition.
This ANDA filing is the first this year for Florida Pharmaceutical Products, Inc., which plans to submit up to six total applications in 2019 and up to 12 by the end of 2020.
The collaboration includes ANDA development by Bluepharma. FPP will file the ANDA with the FDA and upon approval, FPP will manage product sales, marketing and distribution within the United States. The expected timeline for regulatory approval will enable the product to be available in the fourth quarter of 2020.
"We are excited about this opportunity to work with Bluepharma on this project and to improve the lives of patients who will benefit from this proven treatment", states Larry J. Lapila, President of FPP. Sergio Simoes, VP for Business and Product Development at Bluepharma, adds "Since developing this product and monitoring successful outcomes in international markets, we look forward to receiving FDA approval for our application and partnering with FPP in the United States".
About Florida Pharmaceutical Products, Inc.
Florida Pharmaceutical Products, Inc. (FPP) is a Boca Raton, Florida based pharmaceutical company involved in the development of Generic Pharmaceuticals seeking to gain approval and/or license of niche generic products in a broad range of therapeutic areas for marketing and distribution in the US.
FPP brings affordably priced prescription medications from development to distribution for the benefit of patients.
Bluepharma is a European pharmaceutical company based in Coimbra, Portugal. Bluepharma covers a broad range of activities, from R&D and manufacturing to commercialization of pharmaceutical products, with a main focus on complex products and value-added medicines.
The corporate mission at Bluepharma is to offer pharmaceutical products of the highest quality at competitive prices, contributing to the improvement of patients' health and quality of life.
SOURCE Florida Pharmaceutical Products, Inc.