2016 was Record-Setting Year for Generic Drug Approvals, Reports FDA

March 6, 2017

In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016.  In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic Drugs (OGD), states that “the timing couldn’t be better amid concerns about rising drug prices.”

The following are important to note about this advancement:

  1. OGD approved more than 800 generic drugs in 2016, a new annual high. This number includes both full and tentative approvals, which Uhl states “are granted to applications ready for approval from a scientific perspective, but cannot be fully approved due to patents or exclusivities on the brand-name drug.”
  2. Last year’s performance surpassed the Agency’s previous record of 726 generic drug approvals, achieved in 2015.
  3. Many of the drug approved were ‘first time generics.’ Uhl states that this is typically the first step in lowering drug prices because it drives price competition.
  4. Uhl credits the Generic Drug User Fee Amendments (GDUFA) of 2012 for the OGD’s record-breaking performance, because it “completely reshaped the generic drug program at FDA.”
  5. OGD is on track to meet all of its GDUFA commitments, and in addition to increased approvals, “FDA improved communications processes to alert industry to deficiencies in their applications, which reduces the number of review cycles and supports faster approvals.”

To read the full story, view FDA’s blog post.  For additional details and data related to OGD’s 2016 performance, view the Agency’s annual report.

Are you in the process of developing a generic drug?  Are you seeking FDA-approval of a generic product?  Using our proprietary approach to FDA, we can help with these or any other FDA-related matters.  To learn more about our services and how we can help you, contact us today.


February 16, 2016

Display Devices for Diagnostic Radiology, Part 2: FDA Labeling Requirements for 510(k) Submissions

Last week, we provided you with details on FDA’s recommendations for describing display devices in 510(k) premarket submissions. Did we leave you wanting more? Well if you were wishing for additional...

March 30, 2016

Everything You Should Know about FDA’s Draft Guidance on Abuse-Deterrent Generic Opioids, Part One

Evaluating the Abuse Deterrence of Generic Opioid Drug Products As we recently reported, the prevalence of opioid abuse and overdose have reached epidemic levels in the U.S. over the past decade. In...

February 21, 2017

FDA Responds to Citizen Petition & Publishes Revised BE Recommendations for Difluprednate

On Wednesday, February 15th, the FDA issued a revised draft guidance, entitled “Draft Guidance on Difluprednate.” regarding its bioequivalence recommendations for the product. In the revised...