Professional Documents
Culture Documents
FactsAboutGenericDrugs, FDA
FactsAboutGenericDrugs, FDA
FactsAboutGenericDrugs, FDA
Today, nearly 8 in 10 prescriptions filled in the U.S. are for generic drugs.
GENERIC
BRAND
FDA requires generic drugs to have the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. The generic manufacturer must prove its drug is the same (bioequivalent) as the brand-name drug. All manufacturing, packaging, and testing sites must pass the same quality standards as those of brand-name drugs. Many generic drugs are made in the same manufacturing plants as the brand-name drugs.
$$$ $$$
Thurs
$ $
$$$
Davit et al. Comparing generic and innovator drugs: a review of 12 years of bioequivalence data from the United States Food and Drug Administration. Ann Pharmacother. 2009;43(10):1583-97.
1