Bausch Health up 10% after FDA issues draft guidance on generic Xifaxan 14:30 BHC Shares of Bausch Health are rising after the FDA issued draft guidance on Rifaximin. In terms of establishing bioequivalence, the draft guidance gives companies two options: Option 1, which involves four in vivo bioequivalence studies with pharmacokinetic endpoints and in vitro bioequivalence studies of comparative dissolution, and Option 2, which involves in vivo bioequivalence studies with pharmacokinetic endpoints, in vitro bioequivalence studies of comparative dissolution, and in vivo bioequivalence studies with clinical endpoints, a document posted to the site of the FDA explains. Following the draft guidance publication, Evercore ISI analyst Umer Raffat said the new product specific guidance for generic Xifaxan included a "key change," namely that the new guidance no longer grants a waiver of in vivo testing for the 550 mg strength based on 200 mg testing. By doing this, the FDA added "an extra layer hurdle for generics to jump through," according to Raffat, who adds that generic 550 mg "is really what matters" given that the 550 mg dose is "where 99% of the Xifaxan volume lies." Raffat has an In Line rating on Bausch Health, the maker of branded Xifaxan. In afternoon trading, shares of Bausch Health are up 66c, or about 10%, to $7.63. Reference Link Show Related Items >>
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