Product Approval Summaries

BIOLOGICS

AbbVie has received FDA approval for Humira (adalimumab) for treating non-infectious intermediate, posterior and panuveitis.

DEVICES

FDA has cleared Avitus Orthopaedics’ Avitus Bone Harvester device for gathering autologous bone graft and bone marrow. It allows physicians to gather autografts in a minimally invasive fashion, according to the company.

BioMérieux has received 510(k) clearance from FDA for the expanded use of its Vidas BRAHMS PCT assay for managing sepsis patients with elevated risk of mortality. The company says the assay runs on its Vidas instrument and is designed to measure changes in blood levels of procalcitonin — a peptide precursor of calcitonin and a marker of inflammatory response — to differentiate bacterial infections from viral ones. It adds that the test was originally approved for use in patients in the first day after being admitted to an intensive care unit, but is now cleared for monitoring PCT levels over 96 hours to help physicians make treatment decisions for high-risk sepsis patients.

Cepheid has received clearance for an expanded claim on its Xpert Carba-R test for use directly from rectal swab specimens. The company says the test is an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics, which are widely used in hospitals to treat severe infections. FDA cleared the test in March for detecting and differentiating carbapenemase genes in bacterial isolates. The company describes the test as the first on-demand real-time PCR test for CPOs, which delivers results in about 50 minutes.

Redwood City, CA-based Naya Health has received FDA clearance for its Smart Pump, which uses a hydraulic system instead of air to collect breastmilk. This makes the pump more comfortable and quieter than traditional pumps, according to the company. The system sends data such as how often the mother pumps, to a companion smartphone app, called Naya Health Tracker. The app also allows users to track pumping sessions, record their child’s feedings, and manage breastmilk inventory by telling users which milk in their fridge needs to be used first, says Naya.

FDA has approved ReVision Optics’ Raindrop inlay for implantation in the cornea for patients aged 41 to 65 years who have not had cataract surgery and are unable to focus clearly on near objects or small print and need reading glasses with +1.50 D to +2.50 D of power but do not need glasses or contact lenses for distance vision. According to an FDA news release, it is the second FDA-approved implantable corneal device for correction of near vision in patients who have not had cataract surgery, and the first device to change the shape of the cornea to correct vision.

FDA approves Sandstone Diagnostics’ Trak, a portable centrifuge that offers an easy way to test sperm count at home. According to the company, users fill a disposable propellor-shaped cartridge with their semen, and place it in the centrifuge. The centrifuge spins the sample, separating out the sperm cells (the densest part of semen) from the rest of the fluid and then users can get a visual estimation of their sperm count, and enter the information into a companion app.

HUMAN DRUGS

FDA has approved Gilead Sciences’ Epclusa, the first pill to treat all major forms of hepatitis C for patients with and without liver damage. According to the company, the fixed-dose combination pill combines sofosbuvir, a drug approved in 2013, and velpatasvir, a new drug.

Lannett Company, Inc. has received FDA approval for its ANDA for diazepam oral solution, 5 mg/5 mL, the therapeutic equivalent to the reference listed drug, Roxane Labs’ diazepam oral solution, 5 mg/5 mL.