What is an Abbreviated New Animal Drug Application?
The information necessary to obtain approval to market a generic animal drug is submitted to FDA in the form of an Abbreviated New Animal Drug Application, or ANADA. This information includes, but is not limited to, the following: • Identification or Basis – The proposed generic product and the approved (listed) product that will be copied are identified. • Patent Information – The application provides certification by the applicant that a patent does not exist, that a patent has expired or will soon expire, or that a patent claimed for the approved product is invalid or will not be infringed upon by approval of the abbreviated application. In the latter-case, the generic applicant or sponsor must then notify the sponsor of the approved product application and the owner of the patent that he or she has filed an abbreviated application claiming invalidity or noninfringement of the patent. • Labeling – The application contains copies of the proposed labeling for the generic product and o
