Drugs

Vanda Urges Makary to Intercede in Generic Dispute

Vanda Pharmaceuticals has requested FDA commissioner Marty Makary to reconsider a recent agency decision upholding approvals of two generic versions of Hetlioz (tasimelteon), the company’s drug for non-24-hour sleep-wake disorder. The request follows a July ruling by recently retired CDER director Jacqueline Corrigan-Curay, who sided with the Office of Generic Drugs in rejecting Vanda’s citizen petitions that argued the generics were improperly approved on flawed data.

Vanda has long complained that the bioequivalence studies submitted by generic manufacturers relied on limited patient populations — in some cases only Indian male subjects — and showed unexplained data inconsistencies. In one instance, the company said exposure levels in the bloodstream were more than twice those observed with Hetlioz.

Corrigan-Curay nonetheless concluded that the studies were sufficient to establish bioequivalence. Vanda criticized the decision, saying it reflected FDA bias toward generic approvals “regardless of whether they meet the requisite legal and evidentiary standards.”

According to Vanda, FDA staff have indicated it may take two months for the Office of the Commissioner to determine whether to take up the matter.

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