An abbreviated new drug application (ANDA) contains data which is submitted to FDA for the review and potential approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references.
Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
Basic Generic Drug Requirements are:
- Same active ingredient(s) as in brand-name drug/innovator drug
- Same dosage form
- Same strength, use indications, and form (such as a tablet or an injectable)
- Same route of administration
- Same condition of use
- Inactive ingredients already approved in a similar NDA
- Manufactured under the same strict standards
- 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
The goal of ANDA is:
- To reduce the price of the drug
- To reduce the time development
- Increase the bioavailability of the drug in comparison to reference list drug