Medication Monitor

Generic Name (Trade Name—Company)
July 13, 2011

Fondaparinux sodium injection

(generics—Dr. Reddy's; Alchemia)
First generic version approved


Prophylaxis of deep vein thrombosis (DVT), treatment of DVT, and treatment of acute pulmonary embolism 

Dr. Reddy’s Laboratories and Alchemia Limited announced FDA approval of fondaparinux sodium injection, the first and only bioequivalent generic version of GlaxoSmithKline’s Arixtra. The approval includes the 2.5 mg/0.5 mL, 5.0 mg/0.4 mL, 7.5 mg/0.6 mL, and 10 mg/0.8 mL doses of fondaparinux in prefilled color-coded, single-dose syringes with an automatic needle safety device. This new generic will be manufactured using a patented process developed by Alchemia. According to a company press release, competition is likely to be limited for the foreseeable future because of the complexity involved in manufacturing this generic product.