The OGD had what appears to be another good month, fully approving eighty-eight ANDAs and tentatively approving seventeen ANDAs for a total of 105 approval actions. While a few stragglers may still be lurking and not yet listed on the FDA All Approvals page (here), it looks like a good and productive month for the OGD. Out of the six months in FY 2019, it represents the third highest month for number of full approvals and total approval actions.
We will detail the projected number of approvals and receipts once the official numbers are out later this month, but clearly the OGD is heading for its fourth straight record year for approvals.
