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  • FDA Drug Updates

    FDA New Approvals


    Sanofi announced that the FDA approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. Learn more about Adlyxin

    cobas HPV Test

    The FDA approved the Roche cobas HPV Test as the first test for human papilloma virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid. Learn more about the cobas HPV Test

    Differin Gel

    Galderma announced that its U.S. affiliate, Galderma Laboratories, L.P., received approval from the FDA for Differin Gel (adapalene gel 0.1%) as an over-the-counter treatment for acne. Learn more about Differin Gel

    Exablate Neuro System

    Insightec announced that the FDA has approved its Exablate Neuro system for the non-invasive treatment of essential tremor in patients who have not responded to medication. Exablate Neuro uses focused ultrasound waves to precisely target and ablate tissue deep within the brain with no incisions or implants. The treatment is done under magnetic resonance imaging guidance for real-time treatment monitoring. Learn more about the Exablate Neuro System

    Tecnis Symfony Intraocular Lenses

    Abbott announced that the FDA has approved the Tecnis Symfony Intraocular Lenses for the treatment of cataracts. The Tecnis Symfony lenses provide a full range of continuous high-quality vision following cataract surgery, while also mitigating the effects of presbyopia by helping people focus on near objects. The FDA approval includes a version of the lens for people with astigmatism, the Tecnis Symfony Toric Intraocular Lenses. Learn more about Tecnis Symfony Intraocular Lenses

    FDA First-Time Generic Approvals

    Generic for Tamiflu

    Natco Pharma Limited announced final approval of an Abbreviated New Drug Application containing a paragraph IV certification filed with the FDA for generic versions of Tamiflu oral capsules (Roche’s trade name for oseltamivir phosphate), 30mg, 45mg, and 75mg. Learn more about the generic for Tamiflu

    FDA Recalls

    0.25% Bupivacaine Hydrochloride Injection

    Hospira, Inc. is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level, due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels, and/or low-level allergic response to the particulate. The product is packaged 50 units of 30mL Single-use Teartop Vials per case, (25 Bottles per tray, two trays per case). The lot was distributed nationwide in the U.S. to wholesalers and hospitals between December 2015 and January 2016. Learn more about 0.25% Bupivacaine Hydrochloride Injection

    Amikacin Sulfate Injection Vials

    Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500mg/2mL (250mg/mL) and 1g/4mL (250mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. Amikacin Sulfate Injection 250mg/mL, 2mL and 4mL vials were distributed nationwide through wholesalers, retailers, and pharmacies. Learn more about Amikacin Sulfate Injection Vials

    Angiodynamics Soft Vu Omni Flush Angiographic Catheter

    Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions) is recalling Angiodynamics Soft Vu Omni Flush Angiographic Catheters due to reports of separation of the tip of the catheter from the main body. Tip separation leads to loss of device function, possible surgical intervention to retrieve a separated segment, or other complications such as blocking blood flow to bodily organs. Tip separation can also lead to internal organ injury and cause stroke, kidney failure, and intestinal failure among other serious adverse health consequences, including death. The recalled products include manufacturing dates November 7, 2003 to October 18, 2008, and distribution dates January 5, 2004 to December 3, 2008. Learn more about the Angiodynamics Soft Vu Omni Flush Angiographic Catheter

    AVEA Ventilator

    CareFusion is recalling the AVEA Ventilator because of a faulty fuse on the ventilator’s alarm board, which may cause the ventilator to unexpectedly shut down. If the ventilator shuts down, a patient may not receive necessary oxygen. The use of affected product may cause serious adverse health consequences, including death. Learn more about the AVEA Ventilator

    Comfort Shield Barrier Cream Cloths

    Sage Products is voluntarily initiating a nationwide recall of one lot of Comfort Shield Barrier Cream Cloths to the distributor and healthcare facility/user level. The recall is being initiated due to product contamination with the bacteria Burkholderia cepacia. Topical administration of a product with B. cepacia may cause serious infections in patients whose bodies cannot fight disease or in hospitalized patients, as well as certain other patient groups. These infections could be life-threatening. This recall affects the following lot of Comfort Shield Barrier Cream Cloths: Product Code 7503; NDC Number 53462-915-50; Lot Number 53957; Expiration Date 3/6/2018. The affected lot was distributed to customers between March 31, 2016 and June 8, 2016. Learn more about Comfort Shield Barrier Cream Cloths

    HCG and Sermorelin

    Talon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry, due to FDA concern over a lack of sterility assurance. Administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other complications. The sterile products were distributed to patients and providers nationwide between January 18 and July 18, 2016. Learn more about HCG and Sermorelin

    INRatio and INRatio2 PT/INR Monitor System

    Alere Inc. will be initiating a voluntary withdrawal of the Alere INRatio and INRatio2 PT/INR Monitoring System. In December 2014, Alere initiated a voluntary correction to inform users of the INRatio and INRatio2 PT/INR Monitoring System that patients with certain medical conditions should not be tested with the system. As part of its commitment to ensuring the safety of patients, Alere proactively reported these device concerns to the FDA and began conducting a thorough investigation into these events. Alere is committed to ensuring an orderly transition for patients requiring anti-coagulation monitoring and will provide a timeline to discontinue the product line. Alere will provide further information on patient transition to patients and healthcare providers. Patients should speak with their healthcare providers prior to making any changes to their current PT/INR monitoring practices. Learn more about the INRatio and INRatio2 PT/INR Monitor System

    Oral Liquid Docusate Sodium

    The FDA is alerting healthcare professionals that PharmaTech LLC is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. Learn more about Oral Liquid Docusate Sodium

    VentStar Oxylog 3000 Pediatric Patient Breathing Circuit

    Dräger discovered that the check valve on the circuit may leak. This could result in the patient re-breathing exhaled gas with reduced oxygen concentration and increased carbon dioxide levels. This can lead to serious health consequences, including excessive carbon dioxide in the bloodstream (hypercapnia) and increased acidity in the blood (acidosis), which could lead to death. This issue pertains only to the VentStar Oxylog 3000 Disposable Pediatric Patient Circuit. There is no issue or problem with the Oxylog 3000/3000 plus ventilator. Learn more about the VentStar Oxylog 3000 Pediatric Breathing Circuit

    FDA Alerts

    Fluoroquinolone Antibacterial Drugs

    The FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (ie, taken by mouth or by injection). These medicines are associated with disabling and potentially permanent side effects of the tendons, muscles, joints, nerves, and central nervous system that can occur together in the same patient. As a result, the FDA revised the Boxed Warning, the FDA’s strongest warning, to address these serious safety issues. In addition, the FDA updated other parts of the drug label, including the Warnings and Precautions and Medication Guide sections. Learn more about Fluoroquinolone Antibacterial Drugs