Transfer of Ownership Policy for Generics Updated By FDA

The US Food and Drug Administration (FDA) has made effective a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.

The new MAPP outlines how Orange Book staff in the Office of Generic Drugs will process requests to transfer ownership of a drug application and explains the responsibilities of the current owner of the drug application as well as the new owner.

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. To transfer an application, the current owner must submit documentation stating that all rights are transferred to the new owner, a change of ownership request, and a consolidated list of applications that are being transferred. The new application owner must submit a signed application form as well as an acceptance letter that details their commitment to all agreements and conditions the current owner made, as well as the transfer’s effective date. The new owner also must certify that they have a complete copy of the approved application or will request one from the FDA.

Documentation will be reviewed by Orange Book project managers and/or pharmacists; incomplete requests will be returned for additional documentation prior to approval, according to the MAPP.

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