Drugs

More Novo Nordisk Semaglutide Legal Actions

Novo Nordisk says it is pursuing legal proceedings against two compounding pharmacies for selling adulterated and misbranded drugs claiming to contain semaglutide, the active ingredient in the firm’s Ozempic, Rybelsus, and Wegovy. A company statement identifies the pharmacies as Wells Pharmacy, a nationwide compounding pharmacy network, and Brooksville Pharmaceuticals in Brooksville, FL.

The statement says laboratory testing of semaglutide drugs obtained from the pharmacies found unknown impurities up to 33%, a peptide (BPC-157) FDA determined cannot be safely used in compounded drugs, and/or inaccurate strengths with at least 19% less semaglutide than labeled.

The company says it wants to obtain court orders to prevent the two compounding pharmacies from continuing their unlawful sale of adulterated and misbranded drugs claiming to contain semaglutide. Novo Nordisk also wants a court to prevent Wells Pharmacy from using false or misleading statements claiming or implying that its compounded drug claiming to contain semaglutide has been approved by FDA, that its product has been subjected to the same clinical studies and trials as Novo Nordisk’s FDA-approved semaglutide medicines, and that BPC-157 is beneficial for the human body without disclosing its significant safety risks.

As of 11/29, the statement says, Novo Nordisk has filed 12 legal actions against medical spas, weight loss or medical clinics, and compounding pharmacies to cease and desist from false advertising, trademark infringement, and unlawful sales of non-FDA approved compounded products claiming to contain semaglutide.

So far, the company says, it has successfully obtained preliminary injunctions against six medical spas, medical clinics, and/or weight loss clinics that engaged in false advertising and trademark infringement in connection with their sales of compounded drugs claiming to contain semaglutide, sourced from compounding pharmacies.

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