Drugs

Product Approval Summaries

DEVICES

FDA has cleared a Hologic 510(k) for the Cynosure body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-cleared for treating abdomen and love handles (flanks). Hologic says the device uses a selective wavelength laser to precisely target fat cells under the skin.

FDA has cleared an Etiometry 510(k) for the Inadequate Oxygen Delivery (IDO2) Index for monitoring intensive care unit patients aged 12 years or younger. Originally cleared by the agency in 2016 for tracking the clinical risk of inadequate oxygen delivery to neonatal patients, the new clearance now allows hospitals to use the IDO2 Index for older patients.

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

Read more

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