Norwich Pharmaceuticals had already failed once in its bid to get around an unfavorable US patent-infringement ruling over Bausch Health’s Xifaxan (rifaximin) which has put the brakes on final abbreviated new drug application approval until relative patents expire in October 2029.
Norwich Falls To FDA, Bausch, In Bid For Final US Rifaximin Approval
Federal Court In DC Ruling Adds Another Twist In ‘Skinny Label’ ANDA Saga
Norwich brought suit against the US Food and Drug Administration in its bid to get final approval for its Xifaxan ANDA product with patent-protected indications carved out, following an earlier patent-infringement decision. Now, a court in Washington DC has had its say.
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