FDA Policy/General

Product Approval Summaries

BIOLOGICS

FDA has approved Hospira’s Inflectra (infliximab-dyyb), a biosimilar product referencing Janssen Biotech’s Remicade. The approval covers indications such as: adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; patients with moderately to severely active rheumatoid arthritis in combination with methotrexate; patients with active ankylosing spondylitis; patients with active psoriatic arthritis; and adult patients with chronic severe plaque psoriasis.

DEVICES

FDA has cleared an Advanced Brain Monitoring 510(k) for its Sleep Profiler, an overnight sleep monitor and electroencephalogram for patients with insomnia or mood disorders that is intended for diagnosing sleep apnea.“ A Sleep Profiler PSG2 study result can identify patients with abnormal sleep duration and efficiency, decreased slow wave sleep, and increased cortical arousals, factors which have been associated with increased hypertension, obesity, diabetes, and memory impairment,” the company says. It adds that the device is strapped to the head and includes electrodes on the fingers, chest and torso for monitoring sleep patterns.

FDA has approved a CardioFocus PMA for its HeartLight Endoscopic Ablation System for treating patients with paroxysmal atrial fibrillation (AF). The device differs from other AF options that rely on x-ray or mapping support for guidance, by allowing the electrophysiologist to control the delivery of therapeutic laser energy “for the first time under direct visual guidance, to electrically and durably isolate the pulmonary veins (PVs),” the company says. “The HeartLight System is designed to provide the clinician maximum procedural flexibility with a highly compliant balloon that easily accommodates diverse PV anatomies and laser energy that the clinician delivers under direct endoscopic visualization.”

Medtronic has received FDA approval of a PMA for the Micra Transcatheter Pacing System, the first pacemaker that does not require wired leads to provide an electrical connection between the pulse-generating device and the heart. The self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart, an FDA release says.

HUMAN DRUGS

ANI Pharmaceuticals it has received FDA approval of an ANDA for oxycodone HCl capsules, 5mg for managing moderate to severe acute and chronic pain where the use of an opiod analgesic is appropriate.

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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