FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a Qiagen PMA supplement for QuantiFeron-TB Gold Plus, a fourth-generation blood test for detecting latent tuberculosis (TB) infection. The device adds the company’s proprietary CD8+ technology to “offer the ability to capture a much broader picture of an individual’s immune response to TB infection,” the company says. It also features a standard single-tube blood collection option that allows blood samples to be processed up to 53 hours after venipuncture without affecting the accuracy of the test.

FDA has approved a Hologic PMA supplement for the Genius 3D Mammography exam and its use being superior to standard 2D mammography for routine breast cancer screening of women with dense breasts. The device has been available in the U.S. since 2011, and the newly approved physician labeling is based on clinical studies demonstrating that the exam improves invasive breast cancer detection among women of all breast densities, including those with dense breasts, according to the company. The device was shown to detect 20 to 65% more invasive breast cancers compared to 2D alone, with an average increase of 41%, it says. Between 40-50% of women aged 40 to 74 have dense breasts.

FDA has approved an Ethicon PMA for its Surgicel Powder Absorbable Hemostat, which it describes as an “adjunctive hemostatic solution to control continuous oozing on broad or raw surfaces so they can focus on more important issues during surgery.” The device is made of oxidized regenerated cellulose — the same base material found in all Surgicel products — and it is designed to penetrate through oozing blood to quickly stop bleeding at the source and forms clots that stay intact even when the surgical field is irrigated.

DRUGS

FDA has approved a Teva Pharmaceuticals ANDA for the first generic copy of Gilead’s Truvada (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for treating HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to prevent sexually-acquired HIV infection in adults at high risk. Emtricitabine and tenofovir disoproxil fumarate used for PrEP must only be prescribed to individuals confirmed to be HIV-negative immediately prior to initial use and periodically during use, according to the agency.

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