life-sustaining, or of critical importance to providing health care, or a drug that is on the drug shortage list under section 506E of the FD&C Act (21 U.S.C. 356
life-sustaining, or of critical importance to providing health care, or a drug that is on the drug shortage list under section 506E of the FD&C Act (21 U.S.C.
Antibiotic Injectable Coming Off FDA Shortage ListDa Hee HanPharmD
Since 2022, four GLP-1 drugs, including those indicated for weight loss, have been on FDA’s drug shortage list. As a result, these drugs have not been subject to the “essentially a copy” prohibition on compounding or the quantity restrictions under 503A. As a result, both 503A compoundi...
But last year, the med was blessed to reduce the risk of heart failure in adults who have had the condition or have type 2 diabetes, chronic kidney disease and other cardiovascular risk factors. The drug has shown tantalizing potential to block both SLGT2 in the kidneys and SLG...
be included in Medwatch and 5.7% more likely to receive a black-box warning. These results, in and of themselves,are not particularly concerning, but it’s not entirely clear how reflective they are of actual safety concerns. Because the term “adverse events” isnebulous, and because it...
The shortage first began in February, when Abbott Nutrition’s Sturgis, Mich. plant issued a voluntary recall of some of its powdered infant formula products. On a case-by-case basis, the FDA is allowing formula from that facility to be released to people who need urgent, life-sustaining ...
Today, the U.S. Food and Drug Administration (FDA) is providing an update to the list of ultraviolet (UV) wand products that may present a potential risk of injury. Do not use these UV wands because they may expose the user or any nearby person to unsafe levels of ultraviolet-C (UV-...
MedWatch Safety Alertsare distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. Recent FDA Alerts for Wegovy FDA Clarifies Policies for Compounders as National GLP-1 Supply Begins to Stabilize ...
Unfortunately, the White Paper does not provide further analysis on the generic sterile injectables and instead refers back to FDA’s analysis from 2013-2017. However, a cursory review of the currentFDA Drug Shortageslist shows that of the 115 drugs “currently in shortage,” 76 are injections...