FDA Policy/General

Product Approval Summaries

DEVICES

Becton, Dickinson and Co. has received FDA 510(k) clearance for a new insulin infusion set with BD FlowSmart technology, which features a unique side-ported catheter, which has been developed to improve the insulin flow and reduce the number of flow disruptions, according to the company. It adds that the infusion set also has the smallest insertion needle, which reportedly reduces discomfort during insertion.

Biologic Therapies has received 510(k) clearance from FDA for its Bio-MAC Bone Marrow Aspiration Cannula and Bio-CORE Bone Marrow Biopsy Cannula, which are minimally invasive devices that are inserted into bone with a standard surgical drill. According to the company, the power-driven devices do not cause microfractures in the bone unlike traditional bone marrow aspiration cannulas.

FDA has approved a Nevro Corp. PMA for the Senza spinal cord stimulation system as an aid in managing chronic intractable pain affecting the trunk or limbs, including pain associated with failed back surgery syndrome, low back pain and leg pain. The device can reduce pain without producing a tingling sensation called paresthesia by providing high frequency stimulation (at 10 KHz) and low stimulation amplitudes, according to an agency release.

HUMAN DRUGS

FDA has approved a Pernix Therapeutics supplemental NDA for Treximet (sumatriptan and naproxen sodium) for use in pediatric patients 12 years of age and older for the acute treatment of migraine with or without aura.

Strides Arcolab has received FDA approval for lamivudine and zidovudine tablets USP, 150 mg/300 mg for treating HIV infection in adult and children.

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