ANDA FDA – Abbreviated New Drug Application
In 1984, the Hatch-Waxman Act amended the new drug approval provisions of the FD&C Act to add Section 505(j). Section 505(j) formalized the legal structure for generic drugs, under which an ANDA containing bioequivalence data to a Referenced Listed Drug (RLD), with other information was sufficient for the FDA to consider approval.
The premise of the FD&C Act Section 505(j) is that an ANDA drug is the “same as” the brand name drug (the RLD, defined as the listed drug identified by the FDA).
It is important to note that differences* are allowed in route of administration, dosage form and strength as well as the active ingredient in a combination drug product.
Differences must be approved by the FDA in a suitability petition as not requiring clinical investigations.
If an ANDA is not subject to a suitability petition, it must show that the active ingredient, the route of administration, dosage form, and strength of the new drug are the same as the RLD. The ANDA must include information that the generic version is bioequivalent to the RLD.
The demonstration of bioequivalence is to determine whether the changes in manufacturing or drug product’s formulation affect the rate or extent the active ingredient reaches the primary site of action.
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