FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance

The final guidance contains no significant substantive changes to the draft version, but here are a few interesting tidbits:

  • FDA will respond to comments seeking clarification on the process for obtaining therapeutic equivalence evaluations in a forthcoming guidance document.
  • FDA clarified that petitioned ANDAs are expected to have the same therapeutic effect as the reference listed drug.
  • Revisions to the discussion about what kind of information may be submitted in an ANDA seem to emphasize FDA’s “significant flexibility” on this issue.

As always, the devil is in the details.  Much policy will be developed in the context of individual applications.  For more information on how to strategically approach drug approval pathways (yours or a competitor’s), please contact any of the authors of this alert or the Hogan Lovells lawyer with whom you regularly work.


Authored by Philip Katz and George O'Brien

Philip Katz
Washington D.C.
George O'Brien
Senior Associate
Washington D.C.


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