FDA Policy/General

Product Approval Summaries

DEVICES

FDA has approved a FujiFilm Medical Systems PMA for the Digital Breast Tomosynthesis (DBT), as an optional software upgrade for its ASPIRE Cristalle digital mammography system. “With the DBT software option, the x-ray tube moves through an arc around the breast, acquiring a series of low-dose image slices at different angles, producing a three-dimensional view allowing radiologist to see through tissue less obstructed,” the company says.

FDA has cleared a DePuy Synthes 510(k) for the Viper and Expedium Fenestrated Screw Systems. When used with the company’s Confidence High Viscosity Spinal Cement, the screws are intended to restore the integrity of the spinal column in patients with advanced stage spinal tumors, the company says. The devices can be used in open or percutaneous spinal fusion surgery, it adds.

DRUGS

FDA has approved an Adapt Pharma NDA for Narcan (naloxone) Nasal Spray as a 2mg formulation for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory or central nervous system depression.

FDA has approved two Teva Pharmaceutical Industries NDAs for AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) and ArmonAir RespiClick (fluticasone propionate inhalation powder), both indicated for use in asthma patients. AirDuo is a fixed dose combination product containing the same active ingredients as GlaxoSmithKline’s Advair, indicated for treating asthma in patients aged 12 years and older. ArmonAir is an inhaled corticosteroid containing the same active ingredient as Glaxo’s Flovent, indicated for the maintenance treatment of asthma in patients 12 years and older.

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