FDA approves Dr. Reddy’s generic anticoagulant drug
HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.
Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.
The drug is a generic version of GlaxoSmithKline’s Arixtra. Arixtra had sales of about $340 million during the 12-month period ended in May, according to IMS Health.