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

Related Articles

2019 Telehealth Bill

In 2019, Florida passed the Telehealth Bill which establishes standards of practice for telehealth services, including patient evaluations, record-keeping, and controlled substances prescribing. The bill…

Navigating the Legislative Tides: A Mid-Session Update from the Florida Gastroenterologic Society

As the 2024 Legislative Session in Florida strides past its one-third mark, the Florida Gastroenterologic Society (FGS) remains actively engaged, monitoring and influencing healthcare legislation that impacts gastroenterologists across the state. While thousands of bills are in the mix, only a select few have garnered significant attention. Here’s a concise overview of the key bills and initiatives that FGS is closely watching: