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Bausch Health responds to Norwich Pharmaceuticals’ tentative FDA nod for rifaximin

Xifaxan 200 mg is indicated for travelers' diarrhea and currently contributes less than 1% of Salix’s revenues.

Bausch Health and its gastroenterology business, Salix Pharmaceuticals, has responded to the Food and Drug Administrations tentative approval of Norwich Pharmaceuticals’ rifaximin 200 mg product, which is indicated for travelers diarrhea.

Xifaxan (rifaximin) 200 mg currently contributes less than 1% of Salixs revenues, according to Bausch Health.

[Read more: Bausch Health to spin off eye health business into two separate companies]

The company said that it understands this was a Paragraph III filing, which is made when an abbreviated new drug application, or ANDA, applicant does not intend to market its generic product until the patent expiration. The FDA will therefore not grant full approval until the expiry of the last of the companys Orange Book-listed patents for the Xifaxan (rifaximin) 200 mg product takes place on July 24, 2029.

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

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