Drugs

FDA Approves Otsuka/Lundbeck Schizophrenia Drug

FDA has approved an Otsuka America Pharmaceutical and Lundbeck NDA for Abilify Asimtufii (aripiprazole) a once-every-two-months injection for treating schizophrenia in adults or for maintenance monotherapy treatment of Bipolar I disorder in adults. The companies note that the extended-release intramuscular injectable suspension is not approved for treating patients with dementia-related psychosis.

The aripiprazole concentrations of Abilify Asimtufii were assessed in a pharmacokinetic bridging study. “The once-every-two-months, long-acting injectable formulation in 960 mg and 720 mg prefilled syringes delivers sustained plasma concentrations comparable that demonstrated in studies with Abilify Maintena, a long-acting injectable, resulting in comparable safety and efficacy,” the companies say.

“Results from the pivotal trial 031-201-00181, that enrolled 266 patients, demonstrated that Abilify Asimtufii 960 mg met the primary endpoint criteria establishing similarity of aripiprazole plasma concentrations and thus comparable effectiveness to Abilify Maintena 400 mg over a two-month dosing interval,” they say.

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