Product Approval Summaries

DEVICES

FDA has cleared a CorMatrix Cardiovascular 510(k) for the CorMatrix CanGaroo ECM Envelope for use with cardiac implantable electronic devices including pacemakers and implantable cardioverter defibrillators. The device acts as a pouch to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body, according to the company.

Nonin Medical has received FDA clearance of its Nonin Model 3231 OEM/eHealth finger pulse oximeter, which plugs into a telemedicine hub or kiosk through a USB connector and measures oxygen saturation and pulse rate in pediatric to adult patients. According to the company, the oximeter has features such as CorrectCheck technology, which provides feedback through a digital display if the patient’s finger is not placed correctly in the device and PureSAT Pulse Oximetery (SpO2) technology, which uses intelligent pulse-by-pulse filtering to provide precise oximetry measurements despite conditions such as motion, dark skin tones, low perfusion, rapid and SpO2 changes.

FDA has cleared a Vital Connect 510(k) for its HealthPatch MD biosensor for monitoring patients at home with chronic conditions, and for short-term monitoring after a patient is discharged from a hospital. It also allows caregivers to receive notifications on changes in patient conditions when physiological data falls outside selected parameters via a smartphone or other device, according to the company.

HUMAN DRUGS

Fresenius Kabi has received FDA approval for Kabiven and Perikabiven, parenteral nutrition products in a three-chamber bag, which according to the company, is the only container of its kind available in the U.S. The products contain amino acids with electrolytes, dextrose and lipids (Intralipid 20%). The company says the design of the three-chamber bag keeps the macronutrients separate and shelf-stable until the bag is activated and the contents mixed together for patient use.

FDA has approved an InnoPharma, Inc. ANDA for decitabine for injection, a generic version of Eisai Inc.’s Dacogen, indicated for treating patients with myelodysplastic syndromes (MDS). This includes patients previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

FDA has approved an Iroko Pharmaceuticals supplemental NDA for Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID) for managing osteoarthritis pain. The drug was originally approved in 2013 for treating mild to moderate acute pain in adults.

FDA has approved an expanded indication for Pfizer and Protalix BioTherapeutics’ Elelyso (taliglucerase alfa) for injection for treating Type 1 Gaucher disease pediatric patients. The therapy is now indicated for long-term enzyme replacement therapy for both adult and pediatric patients. Approval was based on pediatric data from 14 patients in two clinical trials.

Strides Arcolab Ltd. has received FDA approval for Buspirone hydrochloride tablets USP, 5 mg, 10 mg, 15 mg and 30 mg, indicated for treating anxiety disorders and the short-term relief of the symptoms of anxiety.

TWi Pharmaceuticals has received final FDA approval for its ANDA for megestrol acetate 125mg/ml oral suspension, a generic equivalent of Par Pharmaceutical’s Megace ES, indicated for treating appetite loss, severe malnutrition, or unexplained, significant weight loss in AIDS patients.