Well summertime and its usual vacation schedule has not put a damper on ANDA approval actions and thus, I am happy to report that posting through August 16th reveal that OGD has issued 41 full approval actions and 7 tentative approval actions. If this pace keeps up for the rest of August, this will be […]
Many of our blog readers have likely encountered moving goal dates for their ANDAs since October 1, 2022 and the beginning of GDUFA III. The GDUFA III Commitment Letter, available here, included several new enhancements to the generic drug user fee program as each iteration of the program has continued to do. The changes made to promote transparency […]
Back on January 30, 2023, I wrote a blog (here) concerning a petition that was filed by Vanda Pharmaceuticals regarding a perceived difference in labeling between the brand and generic drug. In this case (and please see original post to familiarize yourself with the details), the firm claimed that the generic excluded braille from its […]
After a slow start to the month, the steam is beginning to power up and halfway through July, OGD has issued 32 full approval and 9 tentative approval actions, so it looks like it should wind up being a good month if the last week’s proliferation of approvals continues. These figures represent postings of Approval […]
As we know, many drug products are approved initially only for adult patients. The Pediatric Research Equity Act (PREA) of 2003 “gives FDA the authority to require pediatric studies in certain drugs and biological products. Studies must use appropriate formulations for each age group. The goal of the studies is to obtain pediatric labeling for […]
Another bit of good news for generic approvals! June unofficially recorded seventy‑five full‑approval actions and thirteen tentative‑approval actions for a total of eighty‑eight approval actions for the month. The seventy‑five full approvals represent the second highest number of full‑approval actions in a month thus far this FY, with the big daddy still being March with […]
Well, we’re just four months from the end of FY 2023 and the approval numbers still stand strong. In May, the OGD issued sixty‑three full‑approval actions and eighteen tentative‑approval actions for a total of eighty‑one approval actions. Of the sixty‑three full‑approval actions, six were first‑time generic approvals and thirteen (20.6%) were approved in the first cycle. […]
Well, June got off to a rousing start! In the first fifteen days, the OGD issued forty‑six full‑approval actions and nine tentative‑approval actions. This represents one of the best mid‑month totals (fifty‑five) that we’ve seen in a long time. If the month continues at this pace, we’re likely to see over 100 approval actions for […]
A day or so ago, the FDA released Manual of Policy and Procedure (MaPP) 5021.5 titled Assessment of Facility‑Based Deficiency Major‑to‑Minor Reclassification Requests. A MaPP is a document that informs how the FDA will handle, manage, and prosecute a particular issue internally. In this case, it describes how the FDA will adjudicate a request to […]
How do you stop a drug shortage? Make it profitable for more than one, two, or even ten generic companies to sell the drug. History has shown that when five (5) or more players enter a generic field, the drug price drops substantially. Have more than 5-7 players – the price drops to 80% of […]
