Drugs

FDA Seizes Counterfeit Ozempic in Supply Chain

FDA says it seized several hundred units of counterfeit versions of Novo Nordisk’s Ozempic (semaglutide) 1mg injection that had entered the U.S. drug supply chain. The fake drugs were not distributed through the company’s authorized supply channels, according to an agency alert.

Novo Nordisk first alerted the agency about the issue on 4/3. Though six adverse events have been reported in connection with the lot under scrutiny, FDA says none are believed to be linked to the counterfeit products and all reports came directly from Novo Nordisk.

Both the FDA and Novo Nordisk are actively testing the counterfeit products to determine their composition and assess any potential risks to patient safety. As of now, there is no confirmed information regarding the identity, quality, or safety of the seized drugs, the alert says.

FDA is urging patients, healthcare providers, pharmacies, and wholesalers to avoid using, selling, or distributing any Ozempic product labeled with lot number PAR0362 and serial numbers starting with 51746517.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome