West (Lionville, PA) recently received 510(k) clearance from the FDA to market the Vial2Bag device, a needle-free transfer system developed by its Medimop subsidiary that provides a safe and convenient method for adding drugs to any intravenous (IV) bag from a vial or syringe. The Vial2Bag device helps nurses and other health care practitioners avoid needle-stick injuries and increases patient safety by helping to ensure the appropriate reconstitution of drugs prior to IV delivery. The device and system can be used for complete needle-free reconstitution of powdered or lyophilized drugs directly into all manufacturers' IV bags, guaranteeing optimal use of a drug product. The Vial2Bag device reduces the need for drug overfill and helps ensure that a patient receives the appropriate dosage. The product is available as part of a kit or with an appropriate vial adapter. For more information, visit www.westreconstitution.com.
Teva Pharmaceuticals (North Wales, PA) recently received FDA approval for its abbreviated new drug application to market Epoprostenol Sodium for Injection—the first generic version of GlaxoSmithKline's Flolan for Injection. The company's approval is for the 0.5-mg base/vial and 1.5-mg/base/vial strengths as well as the sterile diluent. The product, which is AP-rated, is indicated for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. For more information, visit www.tevausa.com.
Smiths Medical (St. Paul, MN) recently received 510(k) clearance from the FDA for its CADD-Solis Ambulatory Infusion System—a clinically and technologically advanced next generation ambulatory infusion system that enhances patient safety and personalized care for pain management patients. Ambulatory systems administer pain management medications, including narcotics, via a variety of delivery routes including intravenous (IV) and epidural. It is important for these devices to have safeguards, such as safety software and intuitive programming options to help clinicians care for their pain management patients. CADD-Solis Ambulatory Infusion System includes the CADDSolis Ambulatory Infusion Pump, CADDSolis Medication Safety Software, and CADD Medication Cassette Reservoirs and Administration Sets. The CADD-Solis Ambulatory Infusion Pump is small and lightweight to promote patient mobility and clinician convenience. The versatile pump can be used for a variety of pain management therapies and patients. Its large color graphic display screen helps clinicians view and verify pump programs, identify and respond to alarms, and interpret delivery trends and patient activity. CADD-Solis Medication Safety Software is an innovative, therapy-based medication safety system designed to deploy the client?s current best practice management protocols to help reduce the risk of adverse events and promote clinician confidence. CADD Medication Cassette Reservoirs provide a compact, durable, self-contained medication reservoir to promote patient mobility and drug security. The CADD Administration Sets also are available for medication delivery from an IV bag. For more information, visit www.smiths-medical.com.
Sandoz (Princeton, NJ) recently announced the reintroduction of Oxacillin Sodium Injection. The product is the generic equivalent of Bactocill (GlaxoSmithKline) in ADD-Vantage vials (Hospira) in the United States. The company is marketing Oxacillin Sodium Injection in ADD-Vantage vials of 1-g and 2-g base strengths. The product is also available in a 10-g pharmacy bulk package. The ADD-Vantage design keeps the drug and diluent separate until the system is activated just prior to administration. Oxacillin Sodium Injection is indicated in the treatment of infections caused by penicillinase-producing staphylococci which have demonstrated susceptibility to the drugs. For more information, visit www.us.sandoz.com.
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