Product Approval Summaries
DEVICES
FDA has approved an Asuragen de novo submission to allow marketing of the QuantideX qPCR BCR-ABL IS Kit, the first nucleic acid-based quantitation test for use during treatment of chronic myeloid leukemia (CML) patients. The device uses blood specimens from patients with CML to measure the amount of BCR-ABL fusion genes, which can be used to estimate the amount of leukemia cells in a patient when treated with BCR-ABL targeted therapies.
Inova Diagnostics has received FDA 510(k) clearance for the QUANTA Flash dsDNA, Jo-1, and Scl-70 assays. According to the company, QUANTA Flash dsDNA is a highly specific marker which, in conjunction with clinical and other laboratory findings, is used to aid in diagnosing systemic lupus erythematosus. QUANTA Flash Jo-1 is an important marker for polymyositis and dermatomyositis and QUANTA Flash Scl-70 is a classification marker for systemic sclerosis.
FDA has cleared a Medtronic 510(k) for the CD Horizon Fenestrated Screw Set, a cement-augmented pedicle screw which can be used for patients diagnosed with advanced stage tumors involving the thoracic and lumbar spine. The device is intended for use at spinal levels where structural integrity is not severely compromised, the company says. “Cement-augmented screws are designed to restore spinal stability in patients whose life expectancy is insufficient to allow for fusion to occur,” Medtronic says. “When placed into compromised bone, traditional screws run the risk of loosening over time. The ability to utilize cement augmentation directly through a fenestrated screw is a great advancement.”
Medtronic has received FDA approval of a PMA for the Prestige LP Cervical Disc for treating cervical disc disease causing nerve or spinal cord compression at two adjacent levels between the neck’s C3-C7 segments. The device is designed to allow motion in the neck at the operated levels, unlike fusion surgery which does not preserve motion, the company says. Its low profile, ball-and-trough design moves in a range of motions, including bending, rotation, and translation.
FDA has cleared a Relievant Medsystems 510(k) for the Intracept Intraosseous Nerve Ablation System for relieving chronic low back pain that has not responded to at least six months of conservative care and was caused by changes associated with degeneration of spinal vertebral bodies and the nearby intervertebral discs. The device uses radio frequency energy, delivered through specially designed instruments to access and ablate the basivertebral nerve (BVN.) The BVN is a sensory nerve within each vertebral body that transmits the sharp, aching or throbbing pain experienced with degenerated vertebral bodies. Intracept is designed for spine specialists treating one or more levels between L3 and S1 in the lower spine.
Soberlink has received FDA 510(k) clearance for the Soberlink Breathalyzer, a handheld device that healthcare providers can use to remotely monitor patients’ alcohol intake. According to the company, individuals using the device receive a text reminder to take a test, which requires that they blow into it. It uses facial recognition to confirm the user’s identity. The blood alcohol test results are wirelessly transmitted in real time using a private cellular network established by Verizon and the results are uploaded to the company’s cloud-based software program. Soberlink says a portal allows clients, such as physicians, to customize notifications and automated report settings.
FDA has approved a Vasorum Ltd. PMA for the Celt ACD vascular closure device, indicated for arterial puncture closure in both diagnostic and anticoagulated percutaneous interventional cardiology and radiology patients. The device comes in three sizes for safe and effective closure of 5F, 6F and 7F punctures. It was “designed to be more clinically versatile than other devices by allowing physicians to carry out multiple re-stick procedures and addressing a broader range of clinical situations and patient anatomies,” according to the company. “Furthermore the device was designed to help achieve more efficient workflow in the cath lab, by achieving rapid and definitive closure and allowing for earlier ambulation of the patient.”
HUMAN DRUGS
FDA has approved a new, expanded label for Allergan and Adamas Pharmaceuticals’ Namzaric (memantine and donepezil hydrochlorides) extended-release, a once-daily, fixed-dose combination of memantine hydrochloride (a NMDA receptor antagonist) and donepezil hydrochloride (an acetylcholinesterase inhibitor, AChEI) indicated for the treating moderate to severe dementia of the Alzheimer’s type in patients stabilized on Aricept10 mg of donepezil HCl once daily.
Apotex, Mylan, Teva, Par, Sun, Aurobindo, Sandoz, and Glenmark received FDA approval 7/19 of generic copies of AstraZeneca’s cholesterol-lowering Crestor (rosuvastatin).
FDA has approved the use of Eli Lilly and Boehringer Ingelheim’s Synjardy (empagliflozin and metformin hydrochloride) tablets in treatment-naive adults with Type 2 diabetes (T2D) as an adjunct to diet and exercise to improve glycemic control. FDA approved Synjardy 8/2015 for adults with T2D who are not adequately controlled on a regimen containing empagliflozin or metformin.
FDA has expanded the use of the protease inhibitor Janssen Therapeutics’ Prezista (darunavir) to pregnant women with HIV infection. The company says the drug is already indicated for treating HIV-1 infection in adults and children aged 3 years or older, in combination with ritonavir with other antiretroviral agents.
FDA has approved a Valeant Pharmaceuticals and Progenics Pharmaceuticals NDA for Relistor (methylnaltrexone bromide) tablets for treating opioid-induced constipation (OIC) in adults with chronic non-cancer pain. Relistor subcutaneous injection (12 mg and 8 mg) was approved in 2008 for treating OIC in adults with advanced illness who are receiving palliative care and in 2014 for treating OIC in adults with chronic non-cancer pain.