December 2017 ANDA Approval Actions – Not Bad!

While OGD has not published the official numbers for December 2017, it appears from the FDA All Approvals list (here) that OGD fully approved 78 ANDAs and tentatively approved 19, for a total of 97 approval actions.  While this is slightly lower than the previous two months of FY 2018, it is to be expected, since the month is shortened by the holiday season and staffing is lower due to a likely higher amount of time off for employees.  We will report on the official numbers as soon as they are released and will also provide a summary of first quarter activities for approvals and receipts as well as attempt to provide projections for the full fiscal year.