Suitability Petition


If you are in the drug industry, one of the petitions you should know very well is the suitability petition. This petition is the permission document required for a different drug to be put on the market than a drug that exists in the market and is referenced.

In order for your eligibility petition to result in a positive result, you must state the information requested from you completely in your petition. Make sure that the information you share in the petition is correct and complete.

-Name, surname, address, telephone number and e-mail address and the identity of the petitioner.
-Action requested: Description of the proposed  generic product and the requested permitted change(s)
– Description of the requested RNLAD, including dosage form; power and active ingredient(s)
– Side-by-side comparison of proposed label changes for the proposed generic new animal drug and currently approved labeling for RNLAD
– Description of the requested RNLAD, including dosage form; power and active ingredient(s)
-A request for categorical exclusion from the requirement to prepare an environmental assessment under 21 CFR 25.30(h) or an environmental assessment under 21 CFR 25.40.

Suitability Petition FDA

Allowed changes under the Federal Food, Drug, and Cosmetic Act (FD&C law) § 512(n)(3) include:
Method of Application;
Dosage form;
Strength (concentration);
A change in one of the active ingredients in the combination listed for reference new animal drug.

Suitability petitions are a form of Citizen Petition and are submitted through the Dockets Management Division.  How it will be submitted and to whom it will be presented is as important as how the application for eligibility is to be filled out.

What is the ANDA Process?

ANDA stands for an abbreviated new drug application. An abbreviated new drug application (ANDA) contains data submitted to the FDA for review and potential approval of a generic drug product. One of the important processes about the petition of suitability is the ANDA process.


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