An ANDA holder may determine that it no longer wishes to manufacture or market a drug subject to an approved ANDA. However, until withdrawal of approval of the ANDA is made effective, the ANDA holder remains responsible for legal and regulatory requirements related to the drug product including post-approval reporting requirements and payment of any required fees. An ANDA holder may request withdrawal of approval of an ANDA under 21 CFR 314.150(c) if the drug product is no longer being marketed.
An applicant may transfer ownership of its application under 21 CFR 314.72. There is no filing fee for the transfer.
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Glen Park PharmD
Vice President, Regulatory Affairs and Quality Assurance
New York NY
United States
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Original Message:
Sent: 10-Apr-2022 18:16
From: Anonymous Member
Subject: ANDA- GDUFA
This message was posted by a user wishing to remain anonymous
Hi everyone,
1) If for some reason post approval of ANDA, the product is not pursued/manufactured, will the sponsor incur any fees (annually or otherwise)? if yes, how can that be avoided?
2) Discontinued ANDA, when transferred/ bought by a second party, will there be a filing fee again?
Thank you in advance.