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GlaxoSmithKline said that the FDA has issued an approvable letter for its anti-clotting drug Arixtra (fondaparinux sodium). Glaxo is seeking approval to market the drug for use in treating unstable angina, or myocardial infarction. Arixtra is already approved for use during surgery in patients at risk for blood clots. Glaxo said in a statement that it would continue working with the FDA to provide the additional information requested to complete the assessment of Arixtra Global Arixtra sales totaled $44 million in 2005.
Novo Nordisk received FDA approval for NovoLog (insulin aspart [rDNA origin] injection) for a pregnancy Category B rating, further validating the drug as a safe and effective treatment for pregnant women with Type 1 diabetes and their unborn children.