FDA Policy/General

FDA Restricting Unlawful Importing of Xylazine

FDA issued a 2/28 Import Alert intended to restrict the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the U.S. to address what it says is a growing public health concern. An agency statement says xylazine has increasingly been found in illicit drugs such as illicitly manufactured fentanyl and other drugs, and has increasingly been detected in overdose deaths.

According to the statement, veterinarians legitimately use drug products containing xylazine to sedate large animals such as horses and deer, but it is not safe for use in people and may cause serious and life-threatening side effects. The agency says people who use illicit drugs may not be aware of the presence of xylazine.

“The action taken today is designed to ensure that imports of drugs containing xylazine into the country are intended for the legitimate veterinary supply, including active pharmaceutical ingredients en route for processing by a manufacturing facility that makes FDA-approved xylazine, for compounding of animal drugs at state-licensed compounding pharmacies or by licensed veterinarians, as well as approved finished products being imported into the U.S.,” the statement says. “Under the import alert, xylazine offered for import is subject to heightened FDA scrutiny, and FDA staff may detain the shipment if it appears to be in violation of the law. As part of their entry review, FDA staff will consider specific evidence offered by importers that the incoming product is properly labeled, not adulterated, and for legitimate veterinary use.”

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