With four reporting days remaining in April, the Office of Generic Drugs has issued full approval actions on sixty-nine ANDAs and tentative approval actions on thirteen ANDAs for a total of eighty-two approval actions. We remind our readers of the potential difference from actual individual ANDA approvals or actual individual ANDA tentative approvals based on a new footnote found at the bottom of the Activities Report of the Generic Drugs Program (FY 2019) Monthly Performance first appearing sometime in April 2019 (here) and further discussed in our blog post of April 16th (here).
We note that there are reports of approvals listed as ORIG-2 that have been showing up in the FDA approval actions for tentative approvals, which could mean the issuance of a second tentative approval letter for the same ANDA (see example below). However, because there is no clear description of what ORIG-2 means, we can only speculate on its meaning (see example below from the FDA All Approvals list (here):
- 04/17/2019 MINOCYCLINE HYDROCHLORIDE ANDA 203443 ORIG-2 MINOCYCLINE HYDROCHLORIDE MYLAN PHARMS INC Tentative Approval
In addition, there are also ORIG-2 numbers listed for full approvals (see below) for two products with the same ANDA number:
- 04/22/2019 MINOXIDIL (FOR MEN) ANDA 209074 ORIG-2 MINOXIDIL TARO PHARM Approval
- 04/22/2019 MINOXIDIL (FOR WOMEN) ANDA 209074 ORIG-2 MINOXIDIL TARO PHARM Approval
This is even more confusing, because the letter dates for approval/tentative approval of the men’s version of the product actually occurred on December 31, 2018, with tentative approval granted to the women’s version due to exclusivity protection. However, a second letter dated April 22, 2019 also granted approval to (we believe) both the men’s and women’s version (as noted in the All Approvals List, unless there was a reporting error on December 31, 2018 when the men’s product was approved and not reported as such). However, we went back to the December 2018 All Approvals report and, sure enough, both the men’s and women’s versions are listed as approved. Therefore, there is certainly an error in reporting and the numbers were actually reported as four approvals, rather than two. See the FDA Drugs@FDA listing here for April 2019 and for December 31, 2018. Here are the listings:
- 12/31/2018 MINOXIDIL (FOR MEN) ANDA 209074 ORIG-1 MINOXIDIL TARO PHARM Approval
- 12/31/2018 MINOXIDIL (FOR WOMEN) ANDA 209074 ORIG-1 MINOXIDIL TARO PHARM Approval
(Notice the same ANDA numbers and the ORIG-1 vs ORIG-2 designations.)
So, while we are glad to see the OGD succeed in the issuance of approval actions, the industry would be happy to better understand what the reported numbers mean. I am sure there will be more to come on this issue as we look to the OGD to provide further guidance on the new reporting paradigm.