Drugs

FDA Seeks Makena Drug Withdrawal

In a rare product approval reversal, FDA has issued a proposal to withdraw from the market Amag Pharmaceuticals’ Makena (hydroxyprogesterone caproate injection) from the market because a required postmarket study failed to verify clinical benefit in reducing the risk of preterm birth in women who previously had a spontaneous (unexplained) preterm birth. Makena was granted accelerated approval, which required the company to conduct a clinical trial to confirm the drug provided clinical benefit to newborns.

“The required confirmatory trial failed to show that Makena is effective for improving the health of babies born to women with a history of unexplained preterm birth,” an FDA notice says. “We also determined that the available evidence does not show that Makena reduces the risk of preterm birth. Therefore, CDER has proposed that Makena be withdrawn from the market and has issued a notice of opportunity for a hearing (NOOH) to the application holder of Makena, Amag Pharmaceuticals. FDA also sent the NOOH to the application holders for the approved generics to Makena for an opportunity to comment.”

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