Drugs

FDA Nixes Vanda Hetlioz Hearing

FDA has denied a Vanda Pharmaceuticals request for a hearing on the agency’s proposed refusal to approve the company’s sNDA for Hetlioz (tasimelteon) to treat insomnia characterized by difficulties with sleep initiation. The FDA 2/26 decision, signed by acting commissioner and principal deputy commissioner Sara Brenner, says the agency has determined that Vanda “has not stated any genuine and substantial issue of fact that would justify a hearing.”

Brenner said it conclusively appears from the face of the data, information, and factual analyses that no genuine and substantial issue of fact precludes the refusal to approve the application.

“Vanda’s arguments do not raise any dispute about a material fact, are not supported by specifically identified reliable evidence, are not justified by sufficient data or information, or would not change the outcome if resolved in the way Vanda seeks,” she wrote. “Further, FDA finds that a hearing on the sNDA would not be in the public interest.”

Brenner also said the materials in the proceeding conclusively show that the approval criteria related to safety and substantial evidence of effectiveness were not met in the sNDA.

The company’s request for summary judgment and an order approving the sNDA also was denied.

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