Drugs

Switching Generic Levothyroxine Maintains Thyroid Function: Study

An FDA-sponsored study found that for patients undergoing properly monitored levothyroxine treatment over time, those who switched among generic drug products maintained the same level of thyroid function as those who consistently used a single levothyroxine product. As reported in Spotlight on CDER Science, the study was not designed to assess the therapeutic equivalence of levothyroxine products but to compare the effects of product switching to single-product use throughout treatment.

“The researchers’ conclusion, although fully consistent with FDA precepts of bioequivalence and, at the pharmacy level, product interchangeability itself, conflicts with current American Thyroid Association (ATA) guideline recommendations that warn clinicians about potential changes in thyroid function associated with levothyroxine product switching,” the report says. “These results establish evidence that should mitigate concerns such as those raised by the ATA over levothyroxine product switching…. The CDER-sponsored research discussed here suggests that there may be institutional resistance among some stakeholders that may not be supported by real-world evidence.”

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