June 2024 saw 49 full-approval actions and 12 tentative-approval actions for a total of 61 approval actions. If these figures hold, June will tie with March for the lowest number of total approval actions in a month. With May standing at a strong 84 unofficial approval actions, this up-and-down month-by-month scenario appears to be the norm this particular fiscal year. We were hoping that an upward trend would develop, but watching the trend of total approval actions is like jumping on a trampoline—up and down, up and down, up and down.

We will let you know more when the official May numbers arrive in a week or two and we’ll provide some full-FY projections for approvals and ANDA receipts.