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  • FDA Drug Updates

    FDA New Approvals

    Astagraf XL

    Astellas Pharma US, Inc., a United States subsidiary of Tokyo-based Astellas Pharma Inc., announced that the FDA has approved Astagraf XL (tacrolimus extended-release capsules) for the prophylaxis of organ rejection in patients receiving a kidney transplant with mycophenolate mofetil and corticosteroids, with or without basiliximab induction. Astagraf XL is the first once-daily oral tacrolimus formulation available in the United States for kidney transplant recipients.
    For more information, visit: newsroom.astellas.us/2013-07-19-Astellas-Announces-FDA-Approval-of-ASTAGRAF-XL-tacrolimus-extended-release-capsules-for-the-Prophylaxis-of-Organ-Rejection-in-Adult-Kidney-Transplant-Recipients


    Forest Laboratories, Inc. and Pierre Fabre Laboratories announced that Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor was approved by the FDA for the treatment of major depressive disorder in adults. Forest Laboratories Inc. expects Fetzima to be available to wholesalers in the 4th calendar quarter 2013.
    For more information, visit: frx.investorhq.businesswire.com/press-release/corporate-news/forest-laboratories-and-pierre-fabre-laboratories-announce-fda-approval


    The FDA has approved Gilotrif (afatinib) for patients with late stage (metastatic) non-small cell lung cancer whose tumors express specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test. Gilotrif is a tyrosine kinase inhibitor that blocks proteins that promote the development of cancerous cells. It is intended for patients whose tumors express the EGFR exon 19 deletions or exon 21 L858R substitution gene mutations. Gilotrif is being approved concurrently with the therascreen EGFR RGQ PCR Kit, a companion diagnostic that helps determine if a patient’s lung cancer cells express the EGFR mutations. The therascreen EGFR RGQ PCR Kit is manufactured by Qiagen Manchester Ltd., based in the United Kingdom.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm360499.htm


    American Regent Inc., a subsidiary of Luitpold Pharmaceuticals Inc., has announced that Injectafer (ferric carboxymaltose injection) has received FDA approval. Injectafer is a parenteral iron replacement product used for the treatment of iron deficiency anemia in adult patients who have intolerance to oral iron or have had an unsatisfactory response to oral iron. Injectafer is also indicated for iron deficiency anemia in adult patients with non-dialysis dependent chronic kidney disease.
    For more information, visit: www.luitpold.com/documents/news/9Fo4fHAOE0SHYfSyNdTbkw==.pdf

    Lo Minastrin Fe

    Warner Chilcott plc announced that the FDA has approved Lo Minastrin Fe (norethindrone acetate and ethinyl estradiol chewable tablets, ethinyl estradiol tablets and ferrous fumarate tablets) for the prevention of pregnancy. Warner Chilcott is currently developing the commercial launch plans for Lo Minastrin Fe.
    For more information, visit: ir.wcrx.com/releasedetail.cfm?ReleaseID=780196

    Neuropsychiatric EEG-Based Assessment Aid (NEBA) System

    The FDA has allowed marketing of the first medical device based on brain function to help assess attention-deficit/hyperactivity disorder (ADHD) in children and adolescents 6 to 17 years old. When used as part of a complete medical and psychological examination, the device can help confirm an ADHD diagnosis or a clinician’s decision that further diagnostic testing should focus on ADHD or other medical or behavioral conditions that produce symptoms similar to ADHD. The device, the Neuropsychiatric EEG-Based Assessment Aid (NEBA) System, is based on electroencephalogram (EEG) technology, which records different kinds of electrical impulses given off by neurons in the brain and the number of times (frequency) the impulses are given off each second. The NEBA System is a 15- to 20-minute non-invasive test that calculates the ratio of two standard brain wave frequencies, known as theta and beta waves. The theta/beta ratio has been shown to be higher in children and adolescents with ADHD than in children without it. The FDA reviewed the NEBA System through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. NEBA Health manufactures the NEBA System.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm360811.htm

    Simponi Aria

    Janssen Biotech, Inc. has announced the FDA approval of Simponi Aria (golimumab) for infusion for the treatment of adults with moderately to severely active rheumatoid arthritis in combination with methotrexate. Simponi Aria is a fully human anti-TNF monoclonal antibody that targets both soluble and transmembrane bioactive forms of TNF-alpha, a protein that when overproduced in the body due to chronic inflammatory diseases can cause inflammation and damage to bones, cartilage, and tissue. By binding with and blocking TNF-alpha, Simponi Aria helps control inflammation. Simponi Aria also helps to inhibit the progression of further joint damage. The Simponi Aria dose regimen is 2 mg/kg given as an intravenous infusion at weeks 0 and 4, then every 8 weeks thereafter. The infusion is given over a 30-minute period.
    For more information, visit: www.janssenbiotech.com/sites/default/files/pdf/PressRelease07182013.pdf

    Xpert MTB/RIF Assay

    The FDA has allowed marketing of the Xpert MTB/RIF Assay, the first FDA-reviewed test that can simultaneously detect bacteria that cause tuberculosis (TB) and determine if the bacteria contain genetic markers that make them resistant to rifampin, an important antibiotic for the treatment of TB. The new test is less complex to perform than other previous FDA-cleared tests for the detection of TB bacteria. Test results, including the detection of TB bacteria and whether the bacteria are drug resistant, are available in approximately two hours. Traditional methods to detect drug resistant TB usually require one to three months. The FDA reviewed the Xpert MTB/RIF Assay through the de novo classification process, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. The Xpert MTB/RIF Assay is manufactured and marketed by Cepheid.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm362602.htm

    FDA New Indication


    Novartis announced that the FDA has approved Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine) for the prevention of meningococcal disease caused by four strains of the bacterium Neisseria meningitidis in infants and toddlers from 2 months of age. Menveo has been available for use in adolescents and adults (11 to 55 years of age) since February 2010 and in children (2 to 10 years of age) since January 2011.
    For more information, visit: www.novartis.com/newsroom/media-releases/en/2013/1720709.shtml

    FDA Recalls

    Albograft Vascular Graft

    LeMaitre Vascular, Inc. recalled the Albograft Vascular Graft due to blood leaking from the surface of the graft after implantation. The Albograft Vascular Graft is made of synthetic material. It is designed to replace or repair a damaged artery with an abnormal enlargement (aneurysm) or an occlusion caused by a disease. Within the United States, this device was only distributed in Pennsylvania. This device was manufactured in April 2011, and distributed from April 2011 through June 2013. On June 19, 2013, the firm sent an Urgent Field Safety Notice dated June 19, 2013, to all affected customers. Customers were instructed to identify and return the affected devices to LeMaitre Vascular. They in turn will replace the devices.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362217.htm

    Beacon Hill Pharmacy d/b/a Rxtra Solutions

    Beacon Hill Medical Pharmacy d/b/a/ Rxtra Solutions (Beacon Hill) is voluntarily recalling all lots of certain sterile products to the user level. There is a question of sterility assurance for the affected products raised by the FDA. Microbial contamination of products intended to be sterile can lead to serious infections, which may be life-threatening. Beacon Hill has not received any reports of adverse events related to this recall and to date, there is no evidence of contamination in the recalled products or any previously prepared products. These products are packaged in clear or amber sterile injectable vials ranging in size of 1 mL to 100 mL containing liquid solution, suspension, or lyophilized powder. The products are packaged in either individual patient prescription vials or single units in a cardboard box container. The products can be identified via the label format, which will include lot numbers initiating with code 01012013@1 to 07262013@99. The products were distributed nationwide to outlets including hospitals, clinics, and patients who have received orders by directly placing phone calls or faxed prescriptions to the Beacon Hill Medical pharmacy facility in Southfield, Michigan. Beacon Hill began notifying its customers via telephone on July 26, 2013. It will begin initiating recall mailers including formal letters, and will continue to call its patients and providers, and schedule office visits to discuss with physicians further.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm363284.htm

    Benztropine Mesylate Injection

    Nexus Pharmaceuticals Inc. is recalling two lots of Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/mL) in 2 mL single dose vials due to the presence of visible particulate matter in the vials. The product is manufactured by Allergy Laboratories, Inc. and was distributed by Nexus Pharmaceuticals Inc. Affected product includes Lot Numbers 030712 and 112911. The administration of particulate, if present in a parenteral drug, poses a safety risk to patients. Sequelae of thromboembolism, some life-threatening (such as pulmonary emboli), may occur. There is also risk for particulates causing phlebitis, mechanical block of the capillaries or arterioles, activation of platelets, subsequent generation of microthrombi, and emboli. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. Administration of a particulate can also lead to formation of granulomas, which represent a protective local inflammatory response to the foreign material and are typically non-serious. Nexus Pharmaceuticals is notifying its distributors and is arranging for return of all recalled products.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363741.htm

    Bryan Medical Tracoe Mini 3.0mm Tracheostomy Tube

    The Tracoe Mini 3.0mm Tracheostomy Tube is intended to be placed into a surgical opening of the trachea to provide safe airway access and to remove discharge from the lungs. These devices are indicated for use in neonatal and pediatric patients. The outside of the device packaging stated a 3.0mm neonatal tube. The product inside the box was actually a 3.0mm pediatric tube. Although the neonatal and pediatric tubes have the same inner diameter, the pediatric tube is 4.0mm longer for this particular model. An oversized tracheostomy tube may cause permanent injury to the trachea. This product may cause serious adverse health consequences, including death. The affected products (Model: 350-3.0, Lot Number: 000-1000071752) were manufactured from December 12, 2012 to January 14, 2013, and distributed from April 9, 2013 to April 12, 2013. On April 17, 2013, Bryan Medical notified its customers by telephone and asked them to return affected devices for replacement.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm361866.htm

    GE Healthcare Nuclear Medicine Systems

    GE Healthcare became aware of an incident at a VA Medical Center facility in the United States. A patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. On July 3, 2013, GE notified hospitals that they were recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. These Nuclear Medicine systems are used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient’s body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology, and other clinical diagnostic imaging applications. Affected products include Infinia Nuclear Medicine Systems, VG and VG Hawkeye Nuclear Medicine Systems, Helix Nuclear Medicine Systems, Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670. Healthcare facilities are instructed to cease use of their Nuclear Medicine system until a GE Healthcare Field Engineer is able to do a complete inspection of the system and perform any necessary repairs at no cost.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362963.htm

    GlideScope Video Laryngoscope (GVL) 3, 4, 5 and GlideScope (AVL) 2, 3, 4, and 5 Reusable Blades

    GlideScope Video Laryngoscope (GVL) and GlideScope Advanced Video Laryngoscope (AVL) reusable blades were recalled due to the potential risk of breakage and premature failure of the blade tip. The GlideScope GVL and AVL are used by qualified medical professionals to obtain a clear, open view of the vocal cords for medical procedures. Device failure may not be readily visible during routine inspection before or after insertion of the laryngoscope. This could result in pieces of the blade breaking off in patients’ mouths and being swallowed or blocking the airway. This product may cause serious adverse health consequences, including hypoxemia, severe cuts to the airway leading to a significant loss of blood, and/or death. On May 10, 2013, Verathon sent “Urgent Medical Devices Recall” letters to all affected customers. The letter identified the problem, affected product, and actions to be taken.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm360250.htm

    LPS Lower Extremity Dovetail Intercalary Component

    The LPS Lower Extremity Dovetail Intercalary component is intended for replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection (eg, tumors, trauma, infections). The FDA and DePuy Orthopaedics notified healthcare professionals of the class 1 recall of the LPS Lower Extremity Dovetail Intercalary Component due to the potential for fracture of the female component, at the dovetail, when exposed to normal physiologic loads while walking. This may also lead to additional pain, infection, loss of function, loss of limb, neurovascular injury, or need for revision surgery. Patients greater than 200 pounds and/or those with high levels of activity are at higher risk of fracture. On July 11, 2013, DePuy issued an Urgent Medical Device Recall informing DePuy distributors, hospitals, and surgeons of the problem and to immediately stop distributing or using the recalled lots. DePuy is providing a patient letter template to assist surgeons with notifying and discussing the risks of the implant fracture and the method for detecting implant failure with their patients. DePuy is not recommending revision or additional follow up in the absence of symptoms of patients with this implanted device.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm363505.htm

    MedStream Programmable Infusion Pump

    The Fill Level Sensor (FLS), a component of the MedStream Programmable Infusion Pump, may malfunction. The FLS is intended to measure the contents of the pump drug reservoir. The malfunction in the FLS may cause the pump’s low reservoir alarm, normally set at 3 mL, to sound too early or too late. On June 7, 2013, Codman issued a Medical Device Corrections Notice to consignees to inform them of a potential problem with the MedStream Programmable Infusion Pump. The notice directed clinicians to evaluate the accuracy of the FLS during each patient’s next scheduled refill session, or sooner if the patient is symptomatic. The firm provided a worksheet (step-by-step instructions) to identify pumps with a miscalibrated FLS and management recommendations for patients with affected devices. No action for physicians is required beyond the recommendations provided in the Medical Device Corrections Notification letter. These affected products were distributed from July 2009 through June 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362038.htm

    Medtronic MiniMed Paradigm Insulin Infusion Sets

    On June 7, 2013, Medtronic sent an urgent medical device safety notification to healthcare professionals to inform them of the potential for over or under delivery of insulin if insulin or other fluids contact the inside of Medtronic Paradigm Tubing Connectors. On June 10, 2013, Medtronic sent an Urgent Medical Device Safety Notification to all Paradigm Insulin pump users and distributors to inform them of this issue. If insulin or other fluids come in contact with the inside of the tubing connector it can temporarily block the vents that allow the pump to properly prime. This can result in too much or too little insulin being delivered, resulting in hypoglycemia or hyperglycemia, which can be severe and lead to serious illness. Affected products were manufactured from October 2001 through June 2013 and distributed from December 2001 through June 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm360663.htm

    Nova Max Glucose Test Strips

    Nova Diabetes Care initiated a voluntary recall of 21 lots of the Nova Max Glucose Test Strips distributed both in the United States and outside the continental United States. Nova Max Plus glucose meter kits that include test strips from the recalled lots are also included in this voluntary recall. The company has recently determined that some of the blood glucose test strips contained within the indicated Nova Max Glucose Test Strip lots and Nova Max Plus glucose meter kits may report a false, abnormally high blood glucose result. A false abnormally high blood glucose result could, under certain conditions, result in an insulin dosing error that could lead to a serious health risk requiring immediate medical attention. Upon identifying the issue, Nova Diabetes Care promptly notified all registered users, healthcare professionals, pharmacies, and distributors where the Nova Max Glucose Test Strip and Nova Max Plus glucose meter kit are recommended or sold. Those who use, recommend clinically, or sell Nova Max Glucose Test Strips for blood glucose testing should immediately discontinue using or distributing glucose test strips from the recalled lots.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362932.htm

    FDA Alerts


    The FDA is informing the public that acetaminophen has been associated with a risk of rare but serious skin reactions. These skin reactions, known as Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis, can be fatal. Reddening of the skin, rash, blisters, and detachment of the upper surface of the skin can occur with the use of drug products that contain acetaminophen. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken. Other drugs used to treat fever and pain/body aches (eg, non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and OTC products. Healthcare professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions. The FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. The FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of OTC acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the same.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm363041.htm

    Mefloquine Hydrochloride

    The FDA is advising the public about strengthened and updated warnings regarding neurologic and psychiatric side effects associated with the antimalarial drug mefloquine hydrochloride. A boxed warning has been added to the drug label. The FDA has revised the patient Medication Guide dispensed with each prescription and wallet card to include this information and the possibility that the neurologic side effects may persist or become permanent. The neurologic side effects can include dizziness, loss of balance, or ringing in the ears. The psychiatric side effects can include feeling anxious, mistrustful, depressed, or having hallucinations. Neurologic side effects can occur at any time during drug use, and can last for months to years after the drug is stopped or can be permanent.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362887.htm

    Nizoral Tablets

    The FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. The FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated. The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm362415.htm