When a reference listed drug (RLD) product is discontinued from marketing, or if the RLD’s NDA application is officially withdrawn, we all know that the FDA must make a determination that the specific RLD was not discontinued from marketing or withdrawn for safety or efficacy reasons before it can approve an ANDA based on the […]
February is a short month in workdays and it may be the same for approvals. Through February 17th, the OGD has issued twenty‑five full‑approval actions and fourteen tentative‑approval actions. With only six reporting days left this month, unless there’s a big surge in the next few days, we may be looking at the fewest approval […]
“A postmarketing requirement (PMR) is a study or clinical trial that an applicant is required by statute or regulation to conduct postapproval. A postmarketing commitment (PMC) is a study or clinical trial that an applicant agrees in writing to conduct postapproval, but that is not required by statute or regulation.” In previous years, the FDA […]
This is something I have not come across in over fifty years in the pharmacy and pharmaceutical business! The issue is related to a drug product called Hetlioz (tasimelteon) capsules, marketed by Vanda. The product is indicated for non‑24‑hour sleep‑wake disorder (non‑24) and nighttime sleep disturbances in Smith‑Magenis Syndrome (SMS) in children and adults. The […]
After initial publication, this post was updated to provide links to the three petitions that FDA denied as mentioned above. https://www.regulations.gov/document/FDA-2020-P-1582-0005 https://www.regulations.gov/document/FDA-2022-P-0600-0005 https://www.regulations.gov/document/FDA-2019-P-5394-0004 The FDA has been struggling with the issue of CBD for quite a while. The use of CBD products in the marketplace has surged with CBD being claimed to be a […]
The biosimilars market is robust and, with continued progress, the savings to patients soar. According to FDA, there are currently 40 licensed biosimilar products and 3 interchangeable biosimilars, 24 of which are currently marketed. And since October of 2021, these products have captured between 3-89% of the market share, depending on the product. With several […]
The Office of Generic Drugs reports that it approved 64 applications that were designated for competitive generic therapy (GCT) program. Since its inception, the program has approved a total of 186 (2 thus far in 2023) applications with the GCT designation. For the 2022 FY, OGD approved 69 ANDA that had GCT designation. Remember that […]
With the United States currently experiencing shortages of Ibuprofen suspension due to an increased demand that the FDA states is caused by “a surge in three viruses: Coronavirus Disease 2019 (COVID-19), respiratory syncytial virus (RSV), and influenza,” the Agency recognizes the need to establish an appropriate enforcement strategy to aid in the availability of this […]
The FDA has been walking a thin line on orphan drug exclusivity (ODE) ever since a September 30, 2021, ruling by the U.S. Court of Appeals for the Eleventh Circuit issued a decision in Catalyst Pharms., Inc. v. Becerra (Catalyst), 14 F.4th 1299 (11th Cir. 2021). in the pre-publication of today’s Federal Register, the FDA […]
Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]
