FLORIDA PHARMACEUTICAL PRODUCTS, LLC ANNOUNCES ANDA APPROVAL and Launch
Boca Raton, FL and Coimbra, Portugal – Florida Pharmaceutical Products, LLC., also known as ‘FPP’ (www.flpharmaproducts.com) and ONConcept® (www.onconceptpharma.com), two pharmaceutical companies involved in development, sales, marketing and distribution of generic pharmaceuticals are pleased to announce the Approval of Abiraterone 500mg Tabs, ANDA generic for Zytiga® (Janssen), from the U.S. Food and Drug Administration (FDA).
ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with • metastatic castration-resistant prostate cancer (CRPC) • metastatic high-risk castration-sensitive prostate cancer (CSPC). Zytiga® peak sales exceeded $600 million. Current generic sales exceed $175 million according to IQVIA™ with limited competition.
This ANDA approval is the first this year for FPP, which expects at least 4 Approvals / Launches in 2023.
The collaboration includes ANDA development by ONConcept®, a strategic collaboration in the field of oncology between three independent and certified European pharmaceutical companies – Bluepharma, Helm and Welding.
ONConcept® developed the product and will manage the supply chain, which comprises a new, state-of-the-art, flexible, sustainable, specialized highly potent oral solid production plant in Portugal, Europe, while FPP will manage product sales, marketing and distribution within the United States. The product is available for immediate launch.
“We are excited about this opportunity for partnership with ONConcept® and to improve the lives of patients who will benefit from these therapies”, states Gina Campbell, SVP Commercial Operations for FPP.
Sergio Simoes, VP at Bluepharma, adds “This ANDA approval reinforces ONConcept® strategy to further growth in the US territory, particularly with reliable partners such as FPP”.
About Florida Pharmaceutical Products, LLC
Florida Pharmaceutical Products, LLC. (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.
ONConcept® project is a reliable, flexible, and high-quality European partnership able to serve global markets with differentiated, high-value medicines.
Portugal-based Bluepharma operates as a CDMO with all the capabilities needed to offer an integrated approach from development to commercial manufacturing. Together with the German partners Helm and Welding, the collaboration bundles its scientific and regulatory knowledge, enlarges the API sourcing network, offers its own intellectual property service, strengthens the individual market knowledge and access to realize a strong highly potent products’ portfolio. Currently the ONConcept® project had built a basket of more than 20 products.