• Arpit J. Patel
• Neha Tiwari
• Pragnesh Patani

An Abbreviated New Drug Application (ANDA) is a written request to the United States Food and Drug Administration (USFDA) to manufacture and market a generic drug in the United States. Abbreviated New Drug Applications are “abbreviated” as they do not require the applicant to conduct clinical trials and require less information than a New Drug Application. In-vivo comparative bioavailability studies are required to be performed to establish the ANDA (generic medicine) is bioequivalent to the already approved product (called reference listed drug) in terms of safety and efficacy. The bioequivalence or therapeutic equivalence is proved in terms of pharmacokinetic or pharmacodynamics or efficacy and safety parameters which is evaluated by establishing the statistical significance between two products and comparison. Once the FDA has approved the submitted ANDA application, the applicant can manufacture and market the generic medicine. Small molecules can be approved by ANDA application. However, biologics and biosimilar products are not comes under generic medicine category as they are prepared by genetic engineering and it requires clinical trials to establish pharmacokinetics, safety, efficacy and immunogenicity of the product.

An Abbreviated New Drug Application (ANDA) submission to US FDA

"An Abbreviated New Drug Application (ANDA) submission to US FDA", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.6, Issue 5, page no.1167-1172, May-2019, Available :http://www.jetir.org/papers/JETIR1905S75.pdf

"An Abbreviated New Drug Application (ANDA) submission to US FDA", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.6, Issue 5, page no. pp1167-1172, May-2019, Available at : http://www.jetir.org/papers/JETIR1905S75.pdf