The FDA Office of Generic Drugs follows a rigorous review process to make sure that, compared to the brand-name (or innovator) medications, the proposed generic medications:
- Contain the same active/key ingredient;
- Have the same strength;
- Use the same dosage form (for instance, a tablet, capsule, or liquid); and
- Use the same route of administration (for instance, oral, topical, or injectable).
FDA's review process ensures that generic medications perform the same way in the human body and have the same intended use as the name brand medication. Health care professionals and consumers can be assured that FDA-approved generic drug products have met the same rigid standards as the innovator drug. All generic drugs approved by FDA have the same high quality, strength, purity, and stability as brand-name drugs. In addition, FDA inspects facilities to make certain the generic manufacturing, packaging, and testing sites pass the same quality standards as those of brand-name drugs.
- Generic Drugs: Questions & Answers
Answers to common questions about generic drugs, including appearance, effectiveness, cost, and other related topics
- Generic Drug Facts
Facts about generic medicines, including review standards, cost, exclusivities, and other related topics
- What Is the Approval Process for Generic Drugs?
Detailed information on FDA's rigorous review process for generic drugs
- The Generic Drug Approval Process (CDER Conversation)
An in-depth interview on FDA's generic drug review with Ted Sherwood, Director, Office of Regulatory Operations, Office of Generic Drugs, Center for Drug Evaluation and Research
- Generic Competition and Drug Prices
Information on how the introduction of generics leads to lower prices for medications