After 12 years on the market under an accelerated approval, the application holder for Makena has failed to provide sufficient efficacy data to the FDA to support continued marketing. The FDA said “[T]oday, the U.S. Food and Drug Administration announced the final decision to withdraw approval of Makena.” The 26 page final decision (here) can […]
I’ve been blogging about the chilling and hugely negative impact that the court decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., No. 18‑1976, have on the delicate balance between the generic and brand‑name industries struck by the Drug Price Competition and Patent Term Restoration Act of 1984 (better known as the Hatch-Waxman Act). I won’t recount the […]
Emergent Bio Solutions received FDA approval today to market an over the counter (OTC) 4mg nasal spray to reverse opioid overdose. What does that mean to the public and the industry? For the public, as soon as the company begins distributing the product, it means easy access to a potentially lifesaving emergency medication to treat […]
When we looked at the mid-month February approvals back on February 22 (here), we projected that February might be a slim month for full approvals and we were right. OGD issued a total of 46 approval actions in February, the lowest total for a month thus far this fiscal year (FY). Of the 46 full […]
This morning, the FDA published the OTC User Fee rates for FY 2023 in a Federal Register notice (here); these rates cover fees for OTC manufacturing facilities (MFD), contract manufacturing organizations (CMO), and OTC monograph order requests (OMORs) for which there are tier 1 and tier 2 requests. A comparison of the first three fiscal years is presented […]
Yesterday, the FDA released additional educational material to aid patients and caregivers in understanding how biosimilars are approved and to explain the differences between and among original biologic products and biosimilars. With more and more biosimilar products hitting the market, these educational tools are designed to make the public more aware of options that they […]
Yesterday, “U.S. Senators Rand Paul (R-KY) and Maggie Hassan (D-NH), both members of the Health, Education, Labor, and Pensions Committee, reintroduced bipartisan legislation to streamline the approval process for generic medications, which are often significantly cheaper than their brand-name counterparts” says a release from Senator Paul’s office (here). If passed, the bill would direct the […]
The FDA released its proposed budget and legislative proposals for FY 2024 (summary can be found here). Besides certain requests for additional funding, reauthorization of the user fee programs for new and abbreviated animal drug programs, a host of safety issues, as well as new record retention requirements to fight data integrity problems in applications and […]
In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them. This is a confusing area for the […]
When we reported the unofficial January approval actions in a previous blog post, there was some concern about how OGD would be reporting their approval and tentative approval actions on the daily report versus the Generic Drugs Program Monthly and Quarterly Activities Report (here). If you go back and read the January unofficial approval blog […]
