Is the generic the same as the brand name? What standards do generic drugs have to meet?
Doctors and patients alike need to feel assured that the generic prescribed is equivalent to the brand name. So, what exactly does that mean? FDA-approved generic drugs have to meet the same rigid standards as the innovator drug (the “brand name”).
To gain FDA approval, a generic drug must:
– Contain the same active ingredients as the brand name drug. However, inactive ingredients may vary, and that is important to know.
– Be identical in strength, dosage form, and route of administration (by mouth, under the tongue, on the skin).
– Have the same use indications (prescribed for the same conditions).
– Be bioequivalent (deliver the same amount of the same active ingredient).
– Meet the same batch requirements for identity, strength, purity, and quality.
– Be manufactured under the same strict standards of the FDA’s good manufacturing practice regulations required for the brand name.