Drugs

FDA Withdrawing Makena, Denies Petition

FDA has denied a 10/8/19 Public Citizen petition asking the agency to (1) withdraw approval of all medications containing hydroxyprogesterone caproate (HPC), approved and marketed as Amag Pharmaceuticals’ Makena and generics, and (2) place HPC on the list of drug products that have been withdrawn or removed from the market for reasons of safety or effectiveness and thus may not be compounded under exemptions in the law. The advocacy organization said it sought the actions because the post-approval confirmatory trial required in the accelerated approval of Makena failed to demonstrate that the drug provides clinical benefit. The drug is indicated to reduce the risk of preterm birth in women with a singleton pregnancy and a history of singleton spontaneous preterm birth.

In its denial letter, FDA says it is initiating proceedings to withdraw approval for Makena because the confirmatory trial failed to verify clinical benefit and Makena is not shown to be effective. The letter says the agency declines to take any action at this time on the approval of generic HPC products referencing an HPC product other than Makena that are not approved for reducing the risk of preterm birth.

FDA says that whether drug products containing HPC may be added to the withdrawn or removed lists for compounding would depend on whether such drugs have been withdrawn or removed from the market because the products or their components are unsafe or not effective.

“Currently, drug products containing HPC have approved applications in effect and remain marketed,” the letter says. “Moreover, the addition of drug products containing HPC to the withdrawn or removed list would require rulemaking. For these reasons, FDA denies your request to immediately place drug products containing HPC on the withdrawn or removed list.”

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

Read more

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