Drugs

AcelRx Pharam NDA Submitted for Pain Drug

An AcelRx Pharmaceuticals 505(b)(2) NDA has been submitted for Dsuvia (sufentanil sublingual tablet, 30 mcg) for treating patients with moderate-to-severe acute pain in a medically supervised setting. The agency has set a user fee target review date of 10/12.

The submission includes data from four trials including SAP301 and SAP202, two randomized double-blind, placebo-controlled studies that enrolled 261 patients (198 received Dsuvia) suffering with moderate-to-severe acute pain due to soft-tissue/visceral (SAP301) or musculoskeletal procedures (SAP202), according to the company. In addition, the data package includes findings from SAP302 and SAP303, two Phase 3 open-label safety and efficacy studies, which enrolled a total of 216 patients with moderate-to-severe acute pain, who had either presented at an emergency department with trauma or injury or undergone various surgical procedures, respectively.

FDA has told AcelRx that it plans to hold an advisory committee meeting to review the Dsuvia application.

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