Drugs

Change Pediatric Acetaminophen Directions: Petition

Parenteral Technologies is petitioning FDA to “publish a statement of enforcement expressly prohibiting the further use of misleading, confusing, and inadequate directions for over-the-counter single-ingredient liquid acetaminophen products for 2-3 years of age, 24-35 pound infants.” The petition calls for the removal and no further use of specific labeling and directions that say, “If possible, use weight to dose.”

The directions are misleading, confusing, and inadequate, the petition says, and thus should be removed or amended. It also says the directions violate the Federal Food, Drug, and Cosmetic Act and are contrary to the format and content requirements for over-the-counter drug product labeling.

The petition concludes that as of 4/24, “the facts remain unclear as to the adverse consequences that may have occurred due to lack of attention to this matter and the decades of previous citizen petitions ‘shelved’ regarding this product. This citizen petition should be expedited as it directly affects millions of vulnerable infants. The petitioner simply requests that FDA comply with its own advisory board’s recommendations, as well [as] enforce its own published statutory regulations and requirements for this product, as it would for any other medication under its control within the United States.”

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