Drugs

FDA Rejects sNDA for Vanda’s Jet Lag Drug

FDA has issued Vanda Pharmaceuticals a complete response letter on a supplemental NDA for Hetlioz (tasimelteon) for treating jet lag disorder. The letter said that “measures” contained in the NDA demonstrating improved sleep have “unclear clinical significance,” according to the company. Vanda previously reported that treated patients slept nearly three hours longer over the three nights following a transatlantic trip than patients following an untreated transatlantic trip.

The company says the letter also contained “additional observations” related to the NDA. “Vanda intends to consider each observation as it plans for continued engagement with the FDA on this matter,” it says.

Last month, Vanda said it had received FDA notification about undisclosed deficiencies that “preclude discussion of labeling and postmarketing requirements/commitments” involving the sNDA (see earlier story).

Vanda says that Hetlioz was shown to be well tolerated prior to its first approval by FDA in 2014 for non-24-hour sleep-wake disorder. “In addition, Vanda has studied Hetlioz for almost 15 years in different settings and conditions, and Hetlioz has consistently demonstrated robust biological effects and clinical benefits,” it says.

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