Product Approval Summaries

DEVICES

Clear Guide Medical has received 510(k) clearance from FDA to market its innovative CT-Ultrasound fusion and image guidance system, the Clear Guide SCENERGY. It will help interventional radiologists and surgeons perform minimally-invasive biopsies and other diagnostic and therapeutic procedures through an integrated display of fused ultrasound and CT images, according to the company. The system is sold as an accessory to most ultrasound machines, the company says.

FDA has approved Medtronic’s Deep Brain Stimulation therapy for use in people with Parkinson’s disease of at least four years duration and with recent onset of motor complications, or motor complications that are not adequately controlled with medication. The device was originally approved in 2002 for use in patients with advanced Parkinson’s disease. The company says it has demonstrated improvement in motor complications, quality of life, activities of daily living and reduction in medication usage in individuals with Parkinson’s.

ScandiDos has received FDA 510(k) clearance for the Delta [4] Discover, a device that independently verifies the radiation dose delivered to a patient during radiation treatment. The in-vivo dosimetry system provides tools for measuring radiation doses delivered during cancer radiation therapies. It also verifies Volumetric Modulated Arc Therapy or RapidArc Radiotherapy Technology treatments on tumors and sets the stage for new treatment modalities, including adaptive radiation therapy, the company adds.

FDA has approved a St. Jude Medical PMA for the MultiPoint Pacing technology featured on the Quadra Assura MP cardiac resynchronization therapy (CRT) defibrillator, the Quadra Allure MP CRT-pacemaker and two new quadripolar Quartet LV leads. St. Jude says the new technology is designed to benefit CRT patients who are not responsive to other pacing alternatives. Clinical data, the company says, have shown that “activating more ventricular tissue faster may enhance heart muscle performance. MultiPoint Pacing technology allows physicians the opportunity to capture more left ventricular tissue quickly by delivering pacing pulses to multiple left ventricle locations rather than the traditional single pulse for each heartbeat.

HUMAN DRUGS

Bracco Diagnostics has received FDA approval of an NDA for Readi-Cat 2 and Readi-Cat 2 Smoothie (barium sulfate) oral suspension for use in computed tomography of the abdomen to delineate the gastrointestinal tract in adult and pediatric patients.

FDA has approved an Impax Laboratories ANDA for dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate (mixed salts of a single-entity amphetamine product) extended-release capsules, CII, 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg, a generic version of Adderall XR to treat attention-deficit hyperactivity disorder.

Lannett Company has received FDA approval for an ANDA for sumatriptan nasal spray USP, 5 mg/spray and 20 mg/spray, the therapeutic equivalent to GlaxoSmithKline’s Imitrex Nasal Spray for treating migraines.

FDA has approved an expanded use for Pfizer’s Ibrance (palbociclib) 125mg capsules — treating hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy. Ibrance first was approved 2/2015 for treating HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine-based therapy in postmenopausal women.

FDA has approved UCB’s Briviact (brivaracetam) as an add-on treatment to other medications to treat partial onset seizures in epilepsy patients age 16 years and older. The agency is requiring that the drug be dispensed with a Medication Guide. “As is true for all drugs that treat epilepsy, the most serious risks include thoughts about suicide, attempts to commit suicide, feelings of agitation, new or worsening depression, aggression, and panic attacks,” an FDA release says.