FDA Updates Policy Manual on Voluntary Withdrawal of Approved ANDAs

The FDA has updated its Manual of Policies and Procedures (MAPP) concerning receiving and processing a request for voluntary withdrawal of an approved abbreviated new drug application (ANDA) to reflect the current procedures in the Office of Generic Drugs (OGD).

The revision of the original Oct. 4, 2017 document was done to include minor clarifications and explain the current process regarding the information that is sent in an ANDA withdrawal request acknowledgment letter.

Until a withdrawal of approval of an ANDA is effective, the ANDA holder must comply with post-approval reporting requirements and payment of any required fees, the agency said.

Read the updated MAPP here: bit.ly/3Ds7ntH.