FDA Policy/General

Product Approval Summaries

DEVICES

Medtronic has received approval from FDA for the Prestige LP Cervical Disc System for treating single-level cervical disc disease (radiculopathy and/or myelopathy).

Quidel Corp. has received FDA clearance to market its AmpliVue GAS Assay for the qualitative detection of Group A β-hemolytic Streptococcus (Streptococcus pyogenes) nucleic acids isolated from throat swab specimens obtained from patients with signs and symptoms of pharyngitis, such as sore throat.

DRUGS

FDA has approved a Boehringer Ingelheim Pharmaceuticals NDA for Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with Type 2 diabetes. The sodium glucose co-transporter 2 inhibitor works by blocking glucose reabsorption in the kidneys, thus increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels, an FDA news release says.

FDA has also approved Boehringer-Ingelheim’s Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease. An agency news release says the spray can be used once daily over a long period of time.

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