Brief Profile :
ANDA is an application that is submitted to the FDA for a US generic drug approval. It is specifically sent to the FDA’s Center for Drug Evaluation and Research, Office of Generic Drugs, to approve a generic drug product. The FDA established this application in 1970. The term “abbreviated” is used for generic drug applications compared to the “new drug application” used for innovator drugs. This term is used because the former is generally not required to include preclinical ( animal and in vitro ) and clinical ( human ) studies data to establish the safety and effectiveness. The FDA usually takes anywhere between six months to years to approve a generic drug post submission of the ANDA. 1 Read about What is the role of USFDA in protecting health?
Scope of ANDA :
- There are four certification letters or clauses of the ANDA, depending on the patent. These are called paragraphs I, II, III, and IV.
- When the ANDA is applied under para I, it indicates that the product’s patent has not been filed. Thus, the FDA may approve the generic version immediately or at the earliest.
- Under para II, applications for generic versions are submitted when the patent for the innovator version has expired. The duration of the approval process is the same as before.
- When the patent has not expired yet but will do so in specific data soon, the ANDA is filed under para III. Under this type, the FDA may approve the generic version on expiration dates or after that.
- When the patent is not valid or infringed, the para IV certification clause is used while filing. To get approval for such products, the FDA sends the generic applicant file notice to the patent holder. If the patent holder does not sue the applicant for this within 45 days, the FDA approves the ANDA.
- A generic company that files for the ANDA approval under para IV and wins the lawsuit is often rewarded with 180 days of marketing exclusivity of the product.
- ANDA approval results in the price of the generic being only slightly below that of the branded version for over six months.
Importance :
- ANDA approval of a generic version ensures that the product is bioequivalent to the branded version. This implies that both have the same absorption rates or bioavailability and comparable active drug blood concentration.
- This application facilitates the approval of generic products without the need for conducting costly and duplicative clinical trials.
- Approved products ( both generic and branded versions ) are generally listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations ( Orange Book ).
Other Relevant Information :
- Product formulation, manufacturer’s procedure, control procedure, testing of the product, dissolution profile, and labeling are some of the data that must be furnished in the ANDA by the applicant.
- Review of bioequivalence, chemistry review, labeling review, and plant inspection are the main steps involved in ANDA approval. Only after getting satisfactory results will the FDA approve the ANDA.
- Electronic submission of ANDA’s is also available. These must be submitted to the FDA Electronic Submission Gateway ( ESG ).