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news.The US Food and Drug Administration (FDA) has approved Dr Reddy's abbreviated new drug application (ANDA) for generic Fondaparinux Sodium Injection.
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Fondaparinux Sodium Injection is the generic version of GlaxoSmithKline’s (GSK) Arixtra which is indicated as a treatment for acute deep vein thrombosis when administered in conjunction with warfarin sodium.
The approved doses of the injection include 2.5mg/ 0.5ml, 5.0mg/ 0.4ml, 7.5mg/ 0.6ml and 10mg/ 0.8ml in prefilled color-coded, single-dose syringes with automatic needle safety device.
Dr Reddy’s will manufacture fondaparinux under license using a patented process developed by Alchemia.
Dr Reddy’s vice-chairman and CEO GV Prasad said the company will execute a phased launch that initially plays to their strengths in select wholesale and retail outlets, and subsequently enhance share over time in the coming quarters to augment the growing annuity of upsides in their North America Generics business.