according to certain courts. While it has been long established that FDA-approved or mandated labeling preempts state failure-to-warn claims, some courts have decided that sometimes labeling just isn’t enough, never mind what FDA thinks. FDA approves (or sometimes...
Contrary to what most people think, just because a drug or device is FDA-approved, it does not mean the product is guaranteed to be safe. In fact,manufacturers recallabout 4,500 drugs and medical devices annually. While the FDA has efforts in place to minimize these safety risks, there ar...
"The approved labeling for Kayexalate describes its potential to decrease absorption of lithium and thyroxine; however, extensive drug-drug interaction studies with Kayexalate have not been performed," the FDA said in a safety communicationpostedon its website today. The action stems from the FDA...
The FDA rejected drug-maker Pharmacia's bid to relax the gastrointestinal (GI) safety warnings on its label for the Cox-2 inhibitor celecoxib (Celebrex). This setback was made only slightly better by changes to the label's section on cardiovascular effects. In reacting to the news, Ph...
products can be used by healthcare professionals for purposes that are not included in the products approved labeling or statement of intended uses. Such off-label uses or treatment regimens, says the FDA, "may be important therapeutic options and may even constitute a medically recognized standard...
Approved: Oct. 2 Company: Novo Nordisk The scoop: While much of the attention on Novo Nordisk revolves around the company’s skyrocketing diabetes and obesity franchises, the Danish drugmaker hasn’t lost sight of smaller indications. Look no further than Rivfloza, a monthly, s...
AstraZeneca has been successful at rolling out its long-acting complement C5 inhibitor Ultomiris in the uses approved for its predecessor Soliris – until now, that is. The drugmaker confirmed this morning that the FDA had baulked at extending the label for Ultomiris (ravulizumab) to include...
Many of these products contain active moieties that FDA had not previously approved, either as a single ingredient drug or as part of a combination product. These products frequently provide important new therapies for patients. Some drugs are characterized as NMEs for administrative purposes, but ...
The FDA's approved label for Paxlovid is limited to treating infected "adults who are at high risk for progression to severe COVID-19." Doctors typically have the freedom to prescribe fully approved drugs "off-label" for other reasons to their patients, beyond the FDA's approval. But bec...
The Food and Drug Administration approved a request by Eli Lilly on Wednesday to begin marketing its tirzepatide medication, which is branded as Mounjaro for diabetes, under a new brand for weight loss as well. While Mounjaro had already been used by some patients "off-label" for weight lo...