Dear Anonymous,
1a) Yes; as long as the application is "active" the ANDA must be maintained in accordance with regulation and any fees paid. 1b) WIthdraw the application and notify FDA.
2) If the ANDA is not withdrawn, the sponsor can transfer the application to the new organization and notify the FDA that the new holder is XXXX and all responsibilities and commitments now belong (transferred) to the new holder. The new holder will let they FDA know they own the ANDA and are then responsible for all maintenance activities and any fees. As far as I know there is no "filing" fee for the new owner who now holds the application. The previous holder must provide the new holder with all regulatory documentation for the product.
I recently worked with a company that purchased product from a company and became the new holder. This was the process I followed and had no issues.
Good luck,
Dar
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Darlene Rosario MBA, RAC
Principle Consultant
Ventura CA
United States
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Original Message:
Sent: 08-Apr-2022 17:19
From: Anonymous Member
Subject: ANDA- GDUFA
This message was posted by a user wishing to remain anonymous
Hello everyone,
1) If an ANDA is approved, but for some reason the sponsor decides not to manufacture/ pursue the product any more, will it still incur the annual fee? if yes, how can that be avoided?
2) If an organization is to buy a discontinued ANDA, what cost pertaining to FDA fee will that incur? will there be a filing fee? etc,.
Thank you in advance