Drugs

Petition Asks FDA Jakafi Safety Labeling Actions

A 3/19 petition filed by Loeb & Loeb on behalf of an unnamed client asks FDA to take specific actions about the adequacy of safety labeling for Incyte’s Jakafi (ruxolitinib) tablets, one of the JAK inhibitor drug products. The petition asks that:

FDA open a public docket to accept comments and views on the necessity of including uniform and consistent Boxed Warnings in the labeling of JAK (Janus Kinases) inhibitor drug products, and particularly in Jakafi tablets;
FDA publish an announcement of the docket opening to ensure the fullest participation;
the docket solicit comments and views on questions included in the petition; and
the docket remain open for no longer than 90 days and that no later than 120 days after the closing of the docket FDA issue a determination on whether, and how, Boxed Warnings should be used in the labeling of Jakafi and that it notify, as appropriate, those sponsors whose approved drugs require safety labeling changes.

The petition includes seven specific, detailed questions and says answers to them will allow the agency to obtain important input from the regulated industry, healthcare providers, researchers, and patients about the drug, its risks, and the most appropriate way to protect public health.

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