FDA publishes new MAPP, Transfer of Ownership (MAPP 5242.1)

MAPP Procedure Template_18Oct2012_Word2010

FDA publishes new MAPP, Transfer of Ownership (MAPP 5242.1)

Today, August 26, 2020, FDA published a new Manual of Policies and Procedures (MAPP 5242.1), “Transfer of Ownership.” This MAPP details how staff in the Office of Generic Drugs (OGD) will process the requests submitted by former and new owners of drug applications to transfer drug application ownership as listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (the “Orange Book”).

The Orange Book is an FDA publication which provides a listing of drugs approved as safe and effective. The Orange Book also serves as the regulatory resource for information on drug marketing availability, bioequivalence, drug substitution, and patent and exclusivity data. The information included in the Orange Book is relied upon by applicants for information required to be included in an abbreviated new drug application (ANDA). OGD is responsible for updating the Orange Book with information relating to drug applications including: change in ownership submissions, corporate merger and acquisition submissions, and changes to marketing status. 

An applicant may transfer ownership of its application under 21 CFR 314.72. At the time of transfer, the new and former owners are required to submit information to the FDA. An applicant may also submit changes in application information relating to corporate mergers and acquisitions.

For full details, please view the MAPP at: https://www.fda.gov/media/141551/download