Dr. Reddy’s announces US FDA approval of Fondaparinux
Dr. Reddy’s will manufacture the drug under licence using an Alchemia process
The US Food and Drug Administration (FDA) has approved Dr. Reddy’s abbreviated new drug application (ANDA) for Fondaparinux Sodium Injection, a bioequivalent generic version of GlaxoSmithKline’s Arixtra.
The approval covers 2.5mg/0.5 mL, 5.0mg/0.4mL, 7.5mg/0.6 mL and 10mg/0.8mL doses of the drug in prefilled colour-coded, single-dose syringes with automatic needle safety device.
Dr. Reddy’s will manufacture fondaparinux under licence using a patented process developed by Australian biotechnology company Alchemia.
G V Prasad, Dr. Reddy’s vice-chairman and chief executive, said the company would execute a phased launch that initially plays to Dr. Reddy’s strengths in selected wholesale and retail outlets, and subsequently enhances its generics business in North America generics business.
Pete Smith, ceo of Alchemia, added: ‘This approval is a major milestone for Alchemia, fondaparinux representing a significant source of potential future income for the company.’
The US patents on Arixtra expired in 2002, the year before the drug was launched in the US.
The Arixtra brand had sales in the US of approximately US$340m for the 12 months to 31 May 2011.