Drugs

Agency Seeks Updated Generic Accutane Labels

FDA is asking all manufacturers of generic drugs citing Accutane (isotretinoin) as the reference-listed drug. An agency statement says the updates are necessary “because new scientific evidence exists that is not reflected in current labeling, and the approved labeling does not follow the current format that better serves healthcare providers…. FDA determined that updating the labeling will benefit public health by improving clarity and supporting safer, more effective use. With improved labeling, healthcare providers will be better equipped to reduce, mitigate, monitor, and manage isotretinoin’s known serious risks.”

The notice says the key updates include:

conversion to Physician Labeling Rule format to meet current legal and regulatory requirements;
consistency with labeling for other drugs containing the same active ingredient or drug class;
enhanced clarity in sections including Warnings and Precautions and Drug Interactions; and
updates to adverse reaction descriptions in combination with MODERN (the Modernizing the Labeling of Certain Generic Drugs Act).

The law established a process for FDA to order labeling updates for generic drugs when their reference-listed drug application has been withdrawn for reasons other than safety or effectiveness.

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