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FDA Defines “First Generic” ANDAs, Asking for Comments

On November 19, 2014, the U.S. Food and Drug Administration (FDA) announced a new criteria for “first generic” abbreviated new drug applications (ANDA).  In July 2012, the U.S. president signed into law the Generic Drug User Fee Amendments of 2012 (GDUFA).  In a GDUFA Commitment Letter, FDA agreed to expedite the review of first generic ANDA applications, which are represented in the letter as public health priorities.

A lack of clear criteria for defining first generic ANDAs caused some confusion for the drug industry, so FDA created specific criteria to help ensure consistent review prioritization.  Currently, FDA defines a first generic application as any received ANDA:

  1. That is a first-to-file ANDA, eligible for 180-day exclusivity, or for which there are no blocking patents or exclusivities


2. For which there is no previously-approved ANDA for the drug product.

FDA is requesting comments and supporting information regarding its announced criteria.  FDA is also seeking comment on whether or not FDA should change the review prioritization for ANDAs that may begin as qualified first generic applications, but which stop fitting the criteria at a later point during their review.  Comments and information may be submitted to FDA online and by mail.

Registrar Corp helps drug companies to comply with U.S. FDA requirements. For questions regarding ANDA applications or other FDA regulations, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Specialist through the 24 hour Live Help service: http://www.registrarcorp.com/livehelp