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 […]
Today, the FDA announced the issuance of a revised draft guidance titled Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA Guidance for Industry (here). This 42‑page guidance supersedes the December 2013 draft guidance of the same name. The document provides updated recommendations and the FDA’s current thinking on the general concepts for […]
With 11 reporting days of August behind us and 11 to go, OGD has issued 31 full approval actions and 2 tentative approval actions. If the current rate holds true for the rest of the month, OGD could be back to well over 60 total approval actions in August. We have seen a slowdown of […]
In previous posts here and here, we outlined the attack on the carveout provisions of the Hatch-Waxman Act (also lovingly known as the “skinny label”) that the crafters of the Act included to ensure that generic drugs could get to consumers if there were certain patents or exclusivity issues that would otherwise block entry into […]
