FDA Announces Initiative to Bolster Generic Dr...(willincrease its communications with gen...),Health

Generic drugs undergo a rigorous scientific review to ensure that they are of high quality, safe, and effective. Generic drug manufacturers must demonstrate that a generic drug has the same dosage form, strength, route of administration, and conditions of use as the approved brand-name product. Generic drug manufacturers also must demonstrate bioequivalence, meaning they show that the drug delivers the same amount of its active ingredient in the same amount of time as the brand-name counterpart. Bioequivalence is a critical requirement for concluding that the original and generic drugs will produce the same therapeutic results.

For more information

Comprehensive information, including audio and video, about FDA's Generic Initiative for Value and Efficiency (GIVE) is available at http://www.fda.gov/oc/initiatives/advance/generics.html

Consumer Q and A: FDA's New Generic Drug Program http://www.fda.gov/consumer/updates/genericsqa100407.html

FDA's Office of Generic Drugs http://www.fda.gov/cder/ogd/

Consumer Inquiries: 888-INFO-FDA