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In 2007, FDA announced in its draft guidance for industry, “Bioequivalence Recommendations for Specific Products,” that the agency was providing product-specific bioequivalence recommendations on its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.

Click here for the announcement of the new recommendations and here for the updated bioequivalence recommendations list. Comments on the updated recommendations can be made until Dec. 4, 2008.