Abstract

A REVIEW ON ABBREVIATED NEW DRUG APPLICATION (ANDA)

Thummala Dharani*, Pachala Prem Kumar, Desaboyina Satya Phanindra, M. V. Nagabhushanam, Brahmaiah Bonthagarala, G. Ramakrishna, Y. Ratna Sindhu and Santosh Kumar Ch.

ABSTRACT

The United States Food and Drug Administration (USFDA) is one of the main regulated agencies wherein the submission and approval of the new drugs is done. This review is based on the process of submission to the ANDA as per FDA norms as described in submission in Federal Food, Drug, and Cosmetic Act (FD and C Act). No drug would exist in the market until it gets accepted by regulatory authorities. The ANDA submission is for those firms seeking to copy branded drugs before running out of patents to get profit on them. A generic applicant must provide in its application a "certification" that a patent submitted to FDA by the brand-name drug's sponsor and scheduled in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). A Generic Product must meet the standards recognized by FDA in Reference listed drugs (RLD). This study concludes the process of ANDA submission to FDA and acts correlated to the submission, the details of ANDA filling.

Keywords: United States Food and Drug Administration (USFDA), Abbreviated New Drug Application (ANDA), Generics, Patents.