First of all, Happy St. Patrick’s Day! The luck of the Irish prevailed last night as, one minute after midnight on March 17th, the Notre Dame Fighting Irish basketball team won its NCAA play-in game in double overtime for a chance to play #6 seed Alabama on Friday. I guess I have some luck too as I will be at that game in San Diego (even though my luck was not driven by Ireland as I don’t have a drop of Irish blood in me)!
Anyway, time to get to business as we look at the number of approval actions that the OGD has taken midway through the month of March. The OGD issued twenty‑two full‑approval actions and four tentative‑approval actions. Not good news so far for the month but we still have half of the month to see an improvement in the numbers. The OGD did approve one biggie this month, right at the midway point, and this was the first generic for Symbicort (Budesonide; Formoterol Fumarate Dihydrate) and the approval went to Mylan on March 15th for its ANDA 211699 for the inhaler product. While the final approval letter is not yet posted on the FDA’s website, the tentative‑approval letter, issued on March 5, 2021, indicated that the original ANDA was submitted on June 26, 2018, close to four years ago. Because the approval letter is not yet posted on DRUGS@FDA, we are unable to read how the patent issues have been resolved and, thus, can’t understand whether the product can be marketed without risk or would need to be marketed at risk if the firm decided to do so.
Have a great St. Patrick’s day! We will continue to keep you up to date on the happenings at the Agency.
