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Only 5 Working Days Left in February, and Month Two of the Elemental Impurities Impact is Being Felt

As of this morning, there were only 20 full ANDA approvals and 2 tentative approvals listed on FDA All Approvals list (here).  In contrast, there were 9 NDAs with full approvals and one tentative approval.  Looks like ANDAs have been more impacted by the elemental impurities (EI) documentation requirement than it has for NDAs.  I don’t know why that would be other than perhaps the new drugs industry players may have been more on top of this requirement?

Based on the process announced by OGD (here) for handling amendments to ANDAs for the inclusion of the EI information, it looks like the ANDA slowdown will last at least 2-3 more months and then hopefully many in the backlog of pending ANDAs with this missing information should hit the approval lists.

We truly believe that there is plenty of time for this hiccup to rectify itself and get back to the trend of increased monthly approval average, but the cost in savings to the American public will take a hit as the delay in approvals means delayed launch for those products that could have been otherwise approved.