FDA Updates Bioequivalence Guidelines

Rockville, MD (Sept. 5)-The US Food and Drug Administration has updated its draft bioequivalence recommendations for several products, and added 66 new draft product-specific guidelines since October 2007. The drug products for which updated draft product-specific bioequivalence recommendations are available include: risedronate sodium, fosinopril sodium/hydrochlorothiazide, fluoxetine HCI/olanzapine, erlotinib HCI, and morphine sulfate.

In 2007, FDA announced in its draft guidance for industry, “Bioequivalence Recommendations for Specific Products,” that the agency was providing product-specific bioequivalence recommendations on its website to solicit public consideration and recommendations. The online process is intended to support drug manufacturers with abbreviated new drug applications.