FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved Medtronic’s Claria MRI Quad Cardiac Resynchronization Therapy Defibrillator (CRT-D) SureScan device for patients with heart failure. The device is approved for scanning in both 1.5 and 3 Tesla magnetic resonance imaging machines, and features EffectivCRT, a new algorithm that personalizes therapy to individual patients by adjusting pacing rates.

FDA has cleared a Xtant Medical Holdings 510(k) for the Irix-C cervical cage for use with autograft or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1. Previously the device was cleared only for use with autogenous bone graft. The device is intended to be used with the company’s 3Demin and OsteoSponge allografts, and its OsteoVive cellular allograft.

FDA has cleared a CapsoVision 510(k) for the CapsoCam Plus small bowel capsule endoscope system. The device comprises a capsule endoscope, a retrieval kit, a data access system, and software, which work together to provide a “streamlined, patient-friendly examination,” the company says.

DRUGS

FDA has approved an Endoceutics NDA for Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), due to menopause. Intrarosa is the first FDA-approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA). Although DHEA is included in some dietary supplements, those products have not been approved to treat or prevent any disease.

FDA has approved a Gilead Sciences NDA for Vemlidy (tenofovir alafenamide, TAF) 25mg, a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease. “Vemlidy is a novel, targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of Gilead’s Viread (tenofovir disoproxil fumarate, TDF) 300mg,” the company says. “Data show that because Vemlidy has greater plasma stability and more efficiently delivers tenofovir to hepatocytes compared to Viread, it can be given at a lower dose, resulting in less tenofovir in the bloodstream. As a result, Vemlidy improved renal and bone laboratory safety parameters compared to Viread.”

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