Drugs

Vanda Petitions FDA Over Teva ‘Non-Braille’Labeling

Vanda Pharmaceuticals has petitioned FDA asking that it immediately revoke the approval of a TEVA ANDA for a generic copy of Vanda’s Hetlioz (tasimelteon) because Teva’s product fails to satisfy the same labeling and same conditions of use requirements. Hetlioz is indicated for treating non-24-hour sleep-wake disorder, which is most common in people with total blindness. Vanda argues that Teva’s label for generic tasimelteon product is not the same as Vanda’s approved Hetlioz label because the Hetlioz label includes Braille writing on the principal display panel of its package, and Teva’s does not.

“FDA’s approval of Teva’s proposed label is therefore contrary to federal law, and thus the agency’s approval of the ANDA must be revoked, and Teva’s product must be recalled, or if necessary, seized,” the petition contends. “The failure of Teva’s ANDA to use the same labeling and same conditions of use as the reference listed drug (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