A generic drug is a medication created to be the same as an existing approved brand-name drug in dosage form, safety, strength, route of administration, quality, and performance characteristics. A generic medicine works in the same way and provides the same clinical benefit as its brand-name version
FDA requires drug companies to demonstrate that the generic medicine can be effectively substituted and provide the same clinical benefit as the brand-name medicine that it copies. The abbreviated new drug application (ANDA) submitted by drug companies must show the generic medicine is the same as the brand-name version in the following ways:
- The active ingredient in the generic medicine is the same as in the brand-name drug/innovator drug.
- The generic medicine has the same strength, use indications, form (such as a tablet or an injectable), and route of administration (such as oral or topical).
- The inactive ingredients of the generic medicine are acceptable.
- The generic medicine is manufactured under the same strict standards as the brand-name medicine.
- The container in which the medicine will be shipped and sold is appropriate, and the label is the same as the brand-name medicine’s label.