The use of novel excipients has potential to assist in the development of better final drug-product formulations for patients. However, drug-product manufacturers are hesitant to use novel excipients in product development because of the uncertainty of the expectations of the FDA and, ultimately, on the FDA’s acceptance of the new excipients in its development program. […]
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, in the pre-publication of the Federal Register (here), the Agency announced a notice of public meeting to receive comments and discuss the material negotiations that have taken place between the industry stakeholders and itself. The notice provides an interesting historical look at the evolution of the PDUFA program since its initial 5-year iteration in […]
We have posted here, here, and here about the inducement to infringe issue that is being brought by an innovator against a generic company. There have been a flurry of other cases that have been brought by other innovators based on initial decisions in that case that, should they stand, impact the inducement to infringe […]
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 […]
