The Agency announced today the first approval of a drug (Ycanth [cantharidin]) available for the treatment of molluscum contagiosum, a viral skin infection that is fairly contagious and is spread by direct skin-to-skin contact. It is approved for use for adults and pediatric patients two (2) years of age and older. However, most infections occur […]
With the latest news that a tornado severely damaged a Pfizer sterile injectable plant in North Carolina, it is clear that Mother Nature is yet another interloper into the drug shortage problem in the United States. Ed Silverman, of the publication STAT, reports that “Among the damaged buildings was a Pfizer plant in Rocky Mount, […]
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 […]
Biosimilars are advancing the cause of affordable medications; however, in some instances, patient savings do not appear to be the primary concern of Pharmacy Benefit Managers (PBMs). The Association of Accessible Medicines (AAM) points to the fact that “[j]ust two weeks ago, the U.S. biosimilars industry entered a new phase when eight biosimilar versions of […]
The FDA answers this question in a newly released guidance titled Postmarketing Studies and Clinical Trials: Determining Good Cause for Noncompliance with Section 505(o)(3)(E)(ii) of the Federal Food, Drug, and Cosmetic Act (here). “[H]olders of applications for human prescription drugs (hereafter applicants) who are required to conduct postmarketing studies or clinical trials under section 505(o)(3) of the […]
I remember working part-time as a pharmacist when I was at FDA and there were only a few prescription oral contraceptives that were available for dispensing at that time. If you had asked then (1984) if I thought that there would ever be an OTC version of an oral contraceptive available, I would have bet […]
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 […]
The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model. Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures. The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]
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. […]
