Product Approval Summaries

BIOLOGICS

FDA has approved The Medicines Company’s Raplixa and RaplixaSpray low-pressure spray applicator to provide adjunctive hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. The company says the fibrin sealant comprised of human-plasma derived fibrinogen and thrombin can be applied directly from the vial or with the RaplixaSpray device in the case of larger bleeding surfaces in difficult to reach areas.

DEVICES

FDA has cleared an FH Ortho 510(k) for the Arrow Reverse Shoulder “long keel” and “short keel” glenoid base plate for use in shoulder surgeries. “The strength of fixation, as well as an outstanding fixation base for bone grafting provides the shoulder surgeon with a new tool in treating the patient with debilitating conditions associated with glenoid deformities,” the company says. The device is indicated for patients with severe shoulder arthropathy and a grossly deficient rotator cuff or a previously failed shoulder joint replacement with a grossly deficient rotator cuff, it says.

FDA has cleared a Monteris Medical 510(k) for two new reduced diameter mini-probes for its NeuroBlate System, a robotic laser thermotherapy tool. The mini-probes have a reduced outer diameter of 2.2 mm. The SideFire Select is a directional laser for contoured ablation of targets while preserving adjacent healthy tissue, whereas the FullFire Select is a diffusing laser designed to provide fast, volumetric ablation in a hyperthermia concentric zone. The devices “can easily be used within a standard MRI bore, and can also be used in conjunction with Monteris Medical's signature Robotic Probe Driver and Mini-Bolt, as well as other skull fixation devices,” the company says.

St. Jude Medical has received FDA approval of its Protégé MRI spinal cord stimulation (SCS) system and MRI compatibility for its 60cm Octrode percutaneous leads for managing chronic pain. According to the company, it is the smallest MR-conditional SCS implantable pulse generator available in the U.S., can be upgraded through software updates once approved rather than through surgical device replacement, and will allow patients to safely undergo head and extremity MRI scans.

HUMAN DRUGS

Alembic Pharmaceuticals, Hetero Labs, Teva, and Torrent Pharmaceuticals has received FDA approval of the first generic versions of Otsuka’s Abilify (aripiprazole), in multiple strengths and dosage forms. It is an atypical antipsychotic drug indicated to treat schizophrenia and bipolar disorder.

FDA has approved GlaxoSmithKline and Theravance’s Breo Elllipta for the once-daily treatment of asthma in patients aged 18 years and older. Breo is administered using the Ellipta dry powder inhaler and consists of a fixed-dose combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2-agonist vilanterol and comes in two strengths, 100/25mcg and 200/25mcg, according to the company.

Kythera Biopharmaceuticals has received FDA approval of an NDA for Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin (submental fat).

FDA has approved a Vernalis plc and Tris Pharma NDA for Tuzistra XR (codeine polistirex and chlorpheniramine polistirex) extended-release oral suspension, indicated for relief of cough and symptoms associated with upper respiratory allergies or a common cold in adults aged 18 years and older. It is indicated for oral use, with or without food, and is to be dosed every 12 hours. The companies say that Tuzistra XR is the only codeine based extended-release oral suspension cough-cold treatment in a U.S. prescription cough cold market.