Today, the FDA issued a new immediately effective guidance entitled “Control of Nitrosamine Impurities in Human Drugs” that replaces the initial guidance by the same name that was issued on February 24, 2021. The new guidance can be found here. The industry has been awaiting the issuance of this revised guidance and the “FDA made […]
Yesterday, the FDA announced the issuance of 14 new product-specific guidances (PSGs) and 54 revised guidances that provide the FDA’s current thinking on the requirements for bioequivalence testing for generic drugs (here). In addition, the FDA updated its list of planned PSG issuances (73 new PSGs) as well as the list of PSGs that it […]
Hard to believe that it’s August 20, 2024 already, with just a little over one month until the end of the FDA’s 2024 Fiscal Year (FY). Time flies when you’re having fun! For today’s peek at approvals, I’m only reporting those through August 15th to increase the accuracy of the figures as the OGD is […]
Today, the FDA released a final guidance titled Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA (here). Wading through the 26-page document is a bit of a chore, but there is a lot of useful information that will provide applicants with advice on what to do, when to do it, and how to […]
If I told you that over 50% of the new novel drugs approved in 2023 are used to treat rare conditions, would you believe me? Well, you should as the chart below shows that 51% (28 of 55) of the novel drugs approved by the Center for Drug Evaluation and Research (CDER) last year were […]
We have written extensively about the attack on the section viii label carve-out that is permitted under the Hatch-Waxman Act (H-W); this carve-out allows certain changes to a generic drug’s labeling to avoid patent infringement or certain exclusivity protection (here, here, here, here, and here). This so-called section viii label carve-out was part of the delicate balance […]
The FDA keeps track of first generic drug approvals for each calendar year and just posted the number for the first six months of calendar year 2024 here. Be aware that the OGD also posts first approvals in its Generic Drugs Program Monthly and Quarterly Activities Report (here) but the first approvals posted on this […]
The official numbers for June 2024 are in and posted on the FDA’s website here. The OGD issued fifty final full approvals along with fifteen tentative approvals in June. Of the fifty approvals, four were first time generic approvals and nine (18%) were first-cycle approvals. Of the fifteen tentative approvals, there were no first-cycle approvals. […]
Based on a Federal Register (FR) notice issued in December 2023 (here), the FDA has determined that ciprofloxacin 100 mg tablets taken in a three-day regimen to treat uncomplicated urinary tract infections are ineffective based on resistance developed over time to E. coli, the primary causative agent for uncomplicated UTIs (see previous post here). Since that time, […]
It seems that the pace of approvals in July 2024 slowed and, as a result, our mid-month estimate of possibly hitting 90 approvals was dashed by a late-month drop in approval actions. The OGD did, however, unofficially issue 63 full-approval actions and 12 tentative-approval actions for a total of 75. (As a reminder, at mid-month, the OGD had […]
