BAUSCH HEALTH COMPANIES WKN: A2JQ1X ISIN: CA0717341071 Kürzel: BHC Forum: Aktien Thema: Hauptdiskussion

Bausch Health (NYSE:BHC) is up 11% after the US FDA issued updated guidance for the company's irritable bowel syndrome with diarrhea drug Xifaxan (rifaximin) that will require generic drugmakers to conduct pharmacokinetic and in vitro bioequivalence studies. According to the guidance, generic drugmakers have two options. They can either conduct four pharmacokinetic bioequivalence studies and in vitro bioequivalence studies (comparative dissolution); or four pharmacokinetic bioequivalence studies, in vitro bioequivalence studies (comparative dissolution), and two clinical endpoint bioequivalence studies. The agency also noted that waiver requests for in vitro testing is "not applicable." The guidance is seen as a blow to companies with rifaximin abbreviated New Drug Applications (ANDAs) seeking to get their products onto the market. In September, the FDA granted tentative approval to Norwich Pharmaceuticals' rifaximin ANDA. In July, a federal judge issued an order in favor of Norwich in a patent dispute on Xifaxan with Bausch Health (BHC).