>Thank you for your message to the Division of Drug Information, Center for
>Drug Evaluation and Research (CDER), one of the five centers within the

>and Drug Administration (FDA).
>
>In order for a drug to be marketed in the United States, it must go through
>an approval process that shows that the drug is safe and effective for its
>intended use. However, generic drug products are not required to replicate
>the extensive clinical trials that have already been used in the

>of the original, brand-name product. Federal law requires that companies
>wishing to obtain approval for generic versions of approved drug products
>must demonstrate that their products are the same as the original drug in
>terms of active ingredients, strength, dosage form, route of

>and labeling. In addition, the applicant must demonstrate that the generic
>form is bioequivalent to the pioneer drug and falls into acceptable
>parameters set for bioavailability, which is the extent and rate at which
>the body absorbs the drug.
>
>The FDA firmly believes that drug products which have gone through the
>approval process, brand name or generic, can be dispensed and used with the
>full expectation that the consumer will receive the same clinical benefit.
>
>However, we at the FDA are interested in learning of product problems that
>patients encounter and to do so have implemented the MedWatch program. It

>a voluntary system of reporting to FDA any product problems. We now have a
>new way to report directly to MedWatch via the Internet. You can find a

>to the Internet voluntary reporting form by going to the MedWatch homepage
>( http://www.fda.gov/medwatch/index.html ),click on "How to Report", then
>"Reporting by Health Professionals" or "Reporting by Consumers". In
>addition, if you would like to report your adverse experience directly to
>the MedWatch Program, please call 1-800-FDA-1088.
>
>Sincerely,
>Drug Information TM