FDA Policy/General

Product Approval Summaries

DEVICES

St. Jude Medical has gained PMA approval for the Infinity Deep Brain Stimulation (DBS) system and its DBS directional leads, which the company describes as the first directional lead approved in the U.S. The device is intended to treat two of the most common movement disorders — Parkinson’s disease and essential tremor.

FDA has approved a label extension for Roche’s EGFR Mutation Test v2 for use with plasma samples as a companion diagnostic for Astra Zeneca’s Tagrisso (osimertinib), which is indicated for patients with metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer.

Adapta Medical has gained 510(k) clearance for the PerfIC Cath intermittent touchless urinary catheter. It is designed for those with a spinal cord injury, multiple sclerosis, diabetes, stroke, spina bifida or other conditions that require a catheter.

DRUGS

FDA has approved Lundbeck’s Carnexiv (carbamazepine) injection as a short-term replacement therapy for carbamazepine formulations in adults with certain seizure types when oral administration is temporarily not feasible.

The agency has approved an Orexo U.S. supplemental NDA for Zubsolv (buprenorphine/naloxone sublingual tablet) 0.7mg/0.18mg for treating patients with opioid dependence.

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