Drugs

Vanda Wants Teva Generic Hetlioz Pulled

Vanda Pharmaceuticals says FDA should revoke its approval of a Teva ANDA for a generic form of Vanda’s Hetlioz (tasimelteon 20 mg capsules), indicated to treat non-24-hour sleep/wake disorder, and order the product recalled because it fails to satisfy the bioequivalence requirement. A Vanda 4/10 petition says Teva flouted the basic principles of and FDA guidance on bioequivalence studies by only testing its drug in 58 males in India.

“To demonstrate bioequivalence,” Vanda writes, “Teva did not test the drug in any women nor in a population representative of the racial and ethnic makeup of the United States. And FDA let it. FDA reviewers disregarded FDA’s own general and specific guidance and rubber-stamped Teva’s woefully inadequate study design. Indeed, an FDA reviewer specifically considered whether the demographic profile of Teva’s study satisfied FDA’s guidance, and the reviewer said ‘Yes.’”

Vanda also cites “serious discrepancies” in Teva’s bioequivalence data and says that the approval of the Teva ANDA without sufficient information to establish bioequivalence to Hetlioz presents a serious risk to patient safety.

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