There is a baking show on Netflix called “Nailed It.” The show is a riot, and its premise is based on amateur bakers trying to copy a creation baked by a famous pastry chef. The amateur baker that comes closest gets a trophy that says, “Nailed It,” even though (in reality) their end-product may look nothing like the professional’s version. Anyway, as far as the approval-action predictions we issued […]
The FDA has updated its first-generic approvals list for calendar year 2021 (here). The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals. As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product […]
On Monday, September 20, 2021, a guidance document entitled Questions and Answers on Quality Related Controlled Correspondence (here) hit the FDA webpage late in the afternoon. This document provides specific recommendations for generic drug quality issues that have been the raised repeatedly through controlled correspondence (CCs) submitted by numerous stakeholders. OGD decided to issue the […]
Through the last posting on the daily approval list on September 16, OGD has reported only 16 full approval actions and one tentative approval action. If this rate keeps up through the rest of the month, we are likely to see the fewest number of monthly approval actions since the beginning of the GDUFA program. […]
Today, the FDA issued a guidance document titled Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers (here). This guidance responds to questions that have been asked by sponsors since the pandemic began, covers a multitude of issues, and outlines some areas of relief for applicants. Remember that the answers […]
The metrics for June appear to be in line with those of other months this FY. There were no big surprises. Here are some of the highlights. The OGD issued only three Refuse-to-Receive (RTR) letters in June, with one for a standard ANDA submission and two for priority submissions. It still seems that priority submissions […]
As of the posting on September 3, 2021, the FDA’s “All Approvals” database (here) listed fifty-five full‑approval actions and eight tentative-approval actions for August. While we know that these numbers can creep up with a couple of stragglers being reported a bit late, the good news is that the OGD hit a total of at […]
The Competitive Generic Therapy (CGT) program, which began in 2017 as a means to bring generics for products that had inadequate competition to market faster, has hit (and actually surpassed) the century mark in terms of the number of approvals. As the FDA notes in its announcement today, the authority for the program comes from […]
We have all seen the FDA announcements about the use of Ivermectin, a drug approved to treat worms in humans and animals (and not to treat COVID), and you have likely seen the now infamous FDA tweet “You are not a horse. You are not a cow. Seriously, y’all. Stop it.” Yet people are continuing […]
In a Federal Register notice (here) that will publish on Monday, August 30th, the FDA announced that it “is withdrawing approval of the abbreviated new drug application (ANDA) for solifenacin succinate tablets, 5 milligrams (mg) and 10 mg, held by Breckenridge Pharmaceutical, Inc.” Breckenridge waived its opportunity for hearing on the proposed withdrawal. What makes this instance so […]
