Xifaxan generic may be stalled until 2029 despite tentative FDA approval

Although the FDA has granted tentative approval to Norwich Pharmaceuticals’ 200 mg generic rifaximin, Bausch Health asserted in a company statement that full approval will not be given until its own rifaximin patent expires in 2029.Unlike the higher-dose formulations, the 200 mg dose of rifaximin (Xifaxan, Bausch Health), is only indicated for treatment of travelers’ diarrhea caused by noninvasive strains of Escherichia coli in patients aged older than 12 years.“The Company understands this was a Paragraph III filing. A Paragraph III filing is made when an Abbreviated NewRead More

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