Drugs

Phoenix Biotechnology Marketing Unapproved Covid Drug: FDA

FDA says its review of Web and social media sites maintained by Phoenix Biotechnology and Avila Herbals, San Antonio, TX, indicate that the companies are marketing an Oleander 4X product manufactured by Avila for Phoenix and intended to mitigate, prevent, treat, diagnose, or cure serious and/or life-threatening conditions such as Covid-19. A 12/15 Warning Letter says the product is legally considered to be an unapproved new drug and asks the companies to take immediate action to stop its sale.

The letter reviews claims for Oleander 4X made on the Web and social media sites that demonstrate that the product is a drug. FDA says that although the companies market Oleander 4X as a homeopathic drug, such drugs are subject to the same statutory requirements as other drugs.

The companies were told to respond with a list of specific actions taken to address the violations cited in the letter and prevent their recurrence, with documentation of each action and a schedule for completing them.

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