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

Bausch Health and its gastroenterology business, Salix Pharmaceuticals, has responded to the Food and Drug Administration’s 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 Salix’s revenues, according to Bausch Health.

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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 company’s Orange Book-listed patents for the Xifaxan (rifaximin) 200 mg product takes place on July 24, 2029.

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