The FDA requires all approved generic products to bе therapeutically equivalent to the reference listed drug in order to receive approval ..
Generic drugs are safe and effective. The FDA requires all approved generic products to bе therapeutically equivalent to the reference listed drug in order to receive approval.
First, а product must bе а Pharmaceutical Equivalent which means: the drug must contain the same active ingredient(s); are of the same dosage form and route of administration; are identical in strength or concentration; and meet the same applicaЫe standards of strength, quality, purity, and identity.
Then, а product that is а Pharmaceutical Equivalent must also bе Therapeutically Equivalent. This means they must have the same clinical effect and safety profile when administered to patients under the conditions specified in the product tabeling.|
Bioequivalence is the measured value that а generic pharmaceutical product performs in the same manner as the pioneer drug. The generic version must deliver the same amount of active ingredients into а patient’s Ыoodstream in the same amount of time as the pioneer drug. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the HatchWaxman Act, estaЫished using Bioequivatence as the basis for approving generic copies of drug products. Brand-name drugs are subject to the same bioequivalency tests as generics when their manufacturers reformulate them.
Please visit http://www.fda.gov/Orugs/default.html for more information.