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Bluepharma signs an agreement with Florida Pharmaceutical Products

18.01.2019 in Bluepharma

The collaboration includes the development and licensing of an ANDA to file with the U.S. Food and Drug Administration (FDA)


Bluepharma Indústria Farmacêutica, S.A. and Florida Pharmaceutical Products, Inc., also known as 'FPP', 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.

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".