OGD approval numbers have surged through June 15th as OGD has already issued 44 full approval actions and 4 tentative approval actions. 14 of those full approvals came on the 15th and 16th of June. Six of those approval actions were for Deferasirox Tablets, 90 mg, a generic of Jadenu. It appears that the block of 6 were approved after the 180-exclusivity of the first filer(s) for that strength.
If the pace of approvals comes close to what we have seen so far this month, then OGD will likely hit a high for the fiscal year. As we all know, ANDA approvals can vary by day, month, or year and making any solid predictions is not often wise. That said, this is a very good beginning to the month of June. The OGD Director and other top OGD officials have always said that there will be good months and bad months. There are several factors that can influence the flow of approvals for instance, inspections, patent and exclusivity expirations, general OGD workload, and OGD waiting for replies from sponsors that may lead to an approval action. Anyway, it is always nice to see the potential for one of those “good” months!
