FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a TransMedics PMA for the Organ Care System Lung platform for use in standard double lung transplants. Approval was based on data from the INSPIRE Trial, the first and largest controlled clinical organ preservation trial in lung transplantation that was conducted at 21 leading international academic institutions, according to the company. The trial’s primary objective was to compare the safety and effectiveness of the device to current cold storage standard of care for preserving donor lungs.

FDA has cleared a Lensar 510(k) for the Lensar Laser System with Streamline IV, that expands the platform’s capabilities to include the creation of the corneal pockets and flaps used in ophthalmic procedures treating presbyopia. The enhancement includes a new curved contact patient interface device that enables the creation of corneal pockets and flaps without compromising patient comfort, the company says. The laser system is cleared for anterior capsulotomy, lens fragmentation, corneal incisions including corneal pockets and flaps, and arcuate incisions.

DRUGS

FDA has approved a Novartis NDA for Afinitor Disperz (everolimus tablets for oral suspension) for the adjunctive treatment of adult and pediatric patients aged two years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures. Approval is based on data from the EXIST-3 Phase 3 study that significantly reduced the frequency of treatment-resistant seizures associated with TSC compared to placebo, according to the company. Afinitor is also currently approved for treating TSC-associated non-cancerous brain tumors (subependymal giant cell astrocytoma) and TSC-associated kidney tumors (renal angiomyolipoma).

FDA has approved a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults. Previously, Exparel was approved for local administration to provide post-surgical analgesia. Interscalene brachial plexus nerve block works by anesthetizing the body’s nerves nearest the shoulder in order to help curb pain, an FDA release explains.

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