We Were Close – June Was A Bit Of A Bust

OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing.  We missed the approval actions by one.  OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of 62 approval actions for June 2019. 

Official Approval, Receipt, and Complete Response Numbers for May and June Slow Out of the Box for ANDA Approvals

The Office of Generic Drugs released its first set of metrics this morning for May which shows (as previously reported here),  83 full approval actions and 12 tentative approval actions (1 more in each category than estimated in the post cited above), for a total of 95 approval actions.  This is the first time this FY that the total has fallen below 100 approval actions in a single month.

March Official Approval Numbers and Receipts Are in – We Were Close!

March 2019 actually saw 89 full approvals and 17 tentative approvals for 106 approval actions (our predictions were off by one).  This is another good month for ANDA approvals, but it is also a month that saw the largest number of ANDA submission for FY 2019 at 118.  We believe this corresponds to the end of the fiscal year for India,