A prescription chemotherapy drug manufactured by Florida-based Breckenridge Pharmaceutical Inc. has earned Food and Drug Administration approval, moving a step closer to combating a rare type of blood and bone marrow cancer.
Breckenridge’s Abbreviated New Drug Application (ANDA) was accepted for Azacitidine, an injected medication dispensed in a single-dose vial containing 100 mg.
Azacitidine is a generic version of Vidaza by Celgene Corp., developed to treat myelodysplastic syndrome (MDS). MDS comprises a group of rare disorders involving the failure of bone marrow to create a sufficient number of healthy red blood cells, white cells or platelets.
Vidaza generated combined sales of $188 million for the 12-month period ending in April 2017, according to industry data reports.
Breckenridge submitted its application to the FDA in conjunction with its partner in development and manufacturing, Natco Pharma Ltd, a global pharmaceutical company with headquarters in Hyderabad, India.
Headquartered in Boca Raton, Breckenridge Pharmaceutical Inc. conducts pharmaceutical research and development as well as nationwide marketing and distribution. Established in 1983, the firm markets generics in many therapeutic categories with over 70 products in a variety of dosage forms.