Drugs

FDA Warns 2 Firms Over Illegal Weight-Loss Drugs

FDA has posted Warning Letters issued to US Chem Labs in Miami, FL, and Synthetix Inc., doing business as Helix Chemical Supply in Bronx, NY, for introducing unapproved and misbranded semaglutide, tirzepatide, and Thymalin products into interstate commerce. The US Chem Labs letter says the company offers on its Web site semaglutide (Novo Nordisk’s Ozempic), tirzepatide (Lilly’s Mounjaro), and thymalin products that all are unapproved new drugs that are also misbranded.

“Despite statements on your product labeling marketing your products as ‘research chemicals only’ and ‘not for human consumption,’ evidence obtained from your Web site establishes that your products are intended for human use,” the letter says. It then lists examples of the Web site claims that establish that the products are drugs intended to prevent, treat, or cure disease conditions and/or affect the body’s structure/function.

FDA says the three products are not generally recognized as safe and effective for their claimed uses and thus are legally new drugs that have not been approved for their uses. The agency says it is particularly concerned that US Chem Labs markets its thymalin product for use in children as the product has not been evaluated by FDA for safety, effectiveness, and quality.

The Helix letter says the company offers for sale unapproved versions of semaglutide and tirzepatide. They also are labeled for “research use only” and “not for human consumption,” the letter says. It then cites Web site claims that establish the products are unapproved new drugs.

Both companies were told to respond with a list of specific actions they have taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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

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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