Drugs

FDA Denies Public Citizen Hetlioz Petition

FDA has denied a Public Citizen 6/11/15 petition asking the agency to revise the Indications and Usage, Carcinogenesis, Mutagenesis, and Pregnancy sections of the labeling for Vanda’s Hetlioz (tasimelteon) capsules. The petition also asked that once the labeling is changed, FDA require distribution of a Medication Guide, require the sponsor to issue a “Dear Doctor” letter about the narrower indication sought in the petition, and require Vanda to conduct a long-term postmarketing clinical trial.

The agency denial letter says FDA continues to believe that the approved indication for treating non-24-hour sleep-wake disorder is appropriate. “We also continue to believe that Hetlioz’ benefits outweigh its risks for its approved indication and that its risks are adequately addressed in the current labeling,” the letter says.

Since FDA sees no need to require labeling changes, the letter says, there is no need for a Medication Guide, “Dear Doctor” letter, or postmarketing safety study.

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