Drugs

Pacira sNDA Resubmitted on Exparel for Pain

FDA has accepted a Pacira Pharmaceuticals supplemental NDA resubmission seeking expansion of its Exparel (bupivacaine liposome injectable suspension) label to include administration via nerve block for prolonged regional analgesia. The agency has set a user fee review action target date of 4/5/2018. Exparel is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia.

FDA issued a complete response letter in 2015 on the original submission. At the time, the agency said Pacira would need to conduct additional Phase 3 studies on Exparel before it resubmitted the application. It requested new trials based upon Exparel’s expected use for a broad spectrum of nerve blocks and not limited to the narrow indication of a single nerve block, the company said.

The sNDA is based on data from a Phase 3 study of Exparel in femoral nerve block in the lower extremity, and a Phase 3 study in brachial plexus block for shoulder surgeries (upper extremity), the company says. It also includes safety and pharmacokinetic data through 120 hours, it adds.

The product combines bupivacaine with DepoFoam that delivers medication over a desired time period. “By utilizing the DepoFoam platform, a single dose of Exparel delivers bupivacaine over time, providing significant reductions in cumulative pain scores with a 45% decrease in opioid consumption,” Pacira 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