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  • FDA Drug Updates

    FDA New Approvals

    Anoro Ellipta

    The FDA has approved Anoro Ellipta (umeclidinium and vilanterol inhalation powder) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease. Anoro Ellipta is a combination of umeclidinium, an inhaled anticholinergic that affects the muscles around the large airways and stops the muscles from tightening, and vilanterol, a long-acting beta2-adrenergic agonist (LABA) that improves breathing by relaxing the muscles of the airways to allow more air to flow into and out of the lungs. The drug carries a boxed warning that LABAs increase the risk of asthma-related death. Anoro Ellipta is manufactured by GlaxoSmithKline.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm379057.htm

    AXIOS Stent and Delivery System

    The FDA has allowed marketing of the AXIOS Stent and Delivery System for treating pseudocysts that form in the pancreas and are next to the stomach or small intestine. This is the first stent that is specifically designed for drainage of a pancreatic pseudocyst by creating a new, temporary opening between the pancreas and the gastrointestinal tract. The FDA reviewed the AXIOS Stent and Delivery System through the de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. The AXIOS Stent and Delivery System is manufactured by Xlumena, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm379195.htm

    Cerena Transcranial Magnetic Stimulator

    The FDA has allowed marketing of the Cerena Transcranial Magnetic Stimulator (TMS), the first device to relieve pain caused by migraine headaches that are preceded by an aura: a visual, sensory, or motor disturbance immediately preceding the onset of a migraine attack. The Cerena TMS is a prescription device used after the onset of pain associated with migraine headaches preceded by an aura. The recommended daily usage of the device is not to exceed one treatment in 24 hours. The Cerena TMS is manufactured by eNeura Therapeutics.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm378608.htm


    The FDA has approved Farxiga (dapagliflozin) tablets to improve glycemic control, along with diet and exercise, in adults with type 2 diabetes. Farxiga is a sodium-glucose co-transporter 2 inhibitor that blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. Farxiga should not be used to treat people with type 1 diabetes; those who have increased ketones in their blood or urine (diabetic ketoacidosis); or those with moderate or severe renal impairment, end stage renal disease, or who are on dialysis. Farxiga is marketed by Bristol-Meyers Squibb Company and AstraZeneca Pharmaceuticals L.P.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm380829.htm

    Feiba NF

    Baxter International Inc. has announced that the FDA granted approval of Baxter's Feiba [Anti-Inhibitor Coagulant Complex] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A or B who have developed inhibitors.
    For more information, visit: www.baxter.com/press_room/press_releases/2013/12_19_13_feiba.html


    Supernus Pharmaceuticals, Inc. announced that the FDA has approved Orenitram (treprostinil), Extended-Release Tablets for the treatment of pulmonary arterial hypertension in WHO Group I patients to improve exercise capacity. Supernus developed the extended-release formulation of Orenitram under a Development and License Agreement with United Therapeutics Corporation. The product uses EnSoTrol, Supernus' novel osmotic technology platform.
    For more information, visit: http://files.shareholder.com/downloads/ABEA-5ZNGZM/2884558920x0x715097/7567b692-1d6c-4a1d-b23d-1196b75b5d43/SUPN_News_2013_12_23_General_Releases.pdf


    The FDA has approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. Sovaldi is a nucleotide analog inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. Sovaldi is to be used as a component of a combination antiviral treatment regimen for chronic HCV infection. Sovaldi was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that treat serious conditions and, if approved, would provide significant improvement in safety or effectiveness. Sovaldi is marketed by Gilead.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377888.htm


    The FDA has approved Tretten, Coagulation Factor XIII A-Subunit (Recombinant), the first recombinant product for use in the routine prevention of bleeding in adults and children who have a rare clotting disorder, known as congenital Factor XIII A-subunit deficiency. Tretten is a recombinant analogue of the human Factor XIII A-subunit that is produced in yeast cells and then further purified. It is a sterile, freeze-dried-powder to be reconstituted with diluent and injected intravenously. Tretten can be administered by a physician or be self-administered. Tretten received orphan-drug designation for this use by the FDA because it is intended for treatment of a rare disease or condition. Tretten is made by Novo Nordisk A/S, Denmark, and is distributed by Novo Nordisk, Inc., USA.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm379696.htm


    The FDA has approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease. Xiaflex is the first FDA-approved non-surgical treatment option for men with this condition who have a plaque (lump) in the penis that results in a curvature deformity of at least 30 degrees upon erection. Xiaflex is a biologic medicine that was first approved by the FDA in 2010 for the treatment of Dupuytren’s contracture, a progressive hand disease that can affect a person’s ability to straighten and properly use their fingers. Xiaflex is believed to work for Peyronie’s disease by breaking down the buildup of collagen that causes the curvature deformity.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377849.htm

    FDA New Indication


    CSL Behring has announced that Kcentra (Prothrombin Complex Concentrate [Human]) has received FDA approval for an expanded indication—urgent reversal of acquired coagulation factor deficiency induced by vitamin K antagonist (eg, warfarin) therapy in adult patients needing an urgent surgery or other invasive procedure. Kcentra was approved by the FDA in April 2013 for the urgent reversal of warfarin therapy in adult patients with acute major bleeding. Kcentra helps restore blood coagulation by replenishing the levels of clotting factors that were depleted by warfarin therapy. Kcentra contains four vitamin K-dependent factors: Factor II (prothrombin), Factor VII, Factor IX, and Factor X, as well as antithrombotic Proteins C and S.
    For more information, visit: www.cslbehring.com/newsroom/Kcentra-Earns-FDA-Approval-for-Use-in-Patients-Undergoing-Surgery

    FDA First Time Generic Approval


    The FDA has approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), a prescription medicine used to treat depression and other conditions. Aurobindo Pharma Ltd., Dr. Reddy’s Laboratories Ltd., Lupin Ltd., Sun Pharma Global FZE, Teva Pharmaceuticals USA, and Torrent Pharmaceuticals Ltd. have received FDA approval to market duloxetine in various strengths.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378282.htm

    FDA Recalls

    5% Dextrose Injection, USP and 0.9% Sodium Chloride Injection, USP

    Baxter International Inc. announced that it has initiated a voluntary recall to the hospital/user level of one lot of 5% Dextrose Injection, USP and four lots of 0.9% Sodium Chloride Injection, USP due to particulate matter found in the solutions. Products affected by this recall were packaged in flexible plastic containers with 96 containers per carton. Affected product was distributed to healthcare centers and distributors in Saudi Arabia, Singapore, United Arab Emirates, and the United States and Puerto Rico. Baxter has notified customers, who are being directed not to use product from the recalled lots. Customers that have product affected by this recall should stop use and arrange for return. The affected lots were distributed to customers between May 2012 and October 2013. Unaffected lot numbers can continue to be used according to the instructions for use.
    For more information, visit: www.baxter.com/press_room/press_releases/2013/12_23_13__iv_solutions.html

    Abrams Royal Pharmacy Sterile Products

    Abrams Royal Pharmacy is voluntarily recalling all unexpired lots of sterile products dispensed nationwide, due to concerns of lack of sterility assurance. All unexpired lots of sterile compounded products are subject to the recall. Sterile products are injectable medications, IVs, eye drops, pellet implants, nasal sprays, inhalation solutions, and eye ointments. All recalled products have a label that includes Abrams Royal Pharmacy’s name and phone as well as a lot number. The recall was issued after a single, isolated report of an adverse event involving a patient in California who received a compounded medication from the pharmacy. Out of an abundance of caution, Abrams Royal is voluntarily recalling all sterile products within expiry. The recalled products were distributed to healthcare facilities, physicians, and patients from June 17, 2013, through December 17, 2013.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm379313.htm

    Clinimix and Clinimix E

    Baxter International Inc. announced that it has initiated a voluntary recall in the United States of two lots of Clinimix and one lot of Clinimix E Injection parenteral nutrition products to the user level, due to complaints of particulate matter found in the products. There have been no reported adverse events associated with this issue to date (as of the January 3, 2014 press release), and the root cause of this voluntary recall has been identified and resolved. The affected product codes are 2B7729 (lot P287045, exp 06/14), 2B7717 (lot P275883, exp 10/13), and 2B7709 (lot P285122, exp 05/14). Affected products were distributed to healthcare centers and distributors in the United States. Baxter has notified customers, who are being directed not to use product from the recalled lots. Customers should locate and remove all affected product from their facilities. The affected lots were distributed to customers between May 2012 and October 2013. Unaffected lot numbers can continue to be used according to the instructions for use.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm380387.htm


    Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck) is initiating a voluntary recall of Gardasil [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]; Lot J007354, due to the potential for a limited number of vials to contain glass particles. This lot was distributed by Merck between August 20, 2013 and October 9, 2013. No other distributed lots of Merck product are affected. Merck’s investigation concluded that for certain vials in the affected lot, the potential exists for small glass particles to be present in the vial. The sterility of the vaccine has not been impacted. If product from this lot has been administered, revaccination is not necessary. The supply of Gardasil will not be impacted by this recall.
    For more information, visit: www.fda.gov/BiologicsBloodVaccines/SafetyAvailability/Recalls/ucm379730.htm

    HeartStart Automated External Defibrillators

    Certain HeartStart automated external defibrillator (AED) devices made by Philips Medical Systems, a division of Philips Healthcare, may be unable to deliver needed defibrillator shock in a cardiac emergency situation, the FDA has stated in a new safety communication for users of these previously recalled devices. The safety communication includes recommendations to better inspect and monitor the readiness of these devices, as well as steps to follow if someone must use a recalled device in an emergency situation. These devices were manufactured and distributed between 2005 and 2012 under the names HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite. In September 2012, Philips Healthcare initiated the recall of HeartStart FRx, HeartStart HS1 Home, and HeartStart HS1 OnSite AEDs due to the failure of an internal electrical component. The recall affected approximately 700,000 devices. In a Medical Device Safety Notice dated November 19, 2013, Philips provided consumers with updated information about the failure of an internal electrical component that could cause the AEDs to fail to deliver a shock. The FDA will continue to closely monitor all AED manufacturers’ quality system practices and manufacturing changes that have persistently contributed to recall and adverse events associated with AEDs. In March 2013, the FDA issued a proposed order that if finalized would require manufacturers of AEDs and accessories to submit premarket approval applications that focus specifically on the critical requirements necessary to assure AEDs are safe and effective. The main objective of this proposed regulatory approach is to improve the reliability of AEDs so that they can continue to save lives.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm377433.htm

    Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial

    Hospira, Inc. has announced that it will initiate a voluntary nationwide recall to the user level for one lot of Lidocaine HCl Injection, USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration date 1AUG2015. The recall is due to a reddish orange particulate on the inner surface and floating in the solution. Lidocaine is packaged 10 units per carton/180 units per case in single-dose glass fliptop vials. The recalled lot was distributed to distributors/wholesalers, hospitals, and pharmacies located in AL, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, MA, MI, MS, MO, NV, NJ, NC, OH, OK, PA, TN, TX, UT, VA, WA, and WI between September 2013 through October 2013. Hospira became aware of the issue after receiving a complaint of particles in the glass vial. To date (as of the December 23, 2013 press release), Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira believes the embedded particulate is related to a supplier’s glass defect. Anyone with an existing inventory should immediately stop use and quarantine any affected product and return the product to Stericycle. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm379739.htm

    Multi Absorber Original

    Vital Signs Devices, a GE Healthcare Company, has initiated a voluntary field corrective action of the disposable Multi Absorber Original after becoming aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber. The Multi Absorber Original may have a thin wall condition, which may lead to small holes in the water (drain tube). This may result in a loss of anesthetic gases, ventilation, and oxygenation. The voluntary corrective action was issued after receiving customer complaints and product returns; upon further inspection, the returned absorbers were found to leak due to a hole in the drain tube. The affected product number is M1173310 containing lot numbers 12001 through 13031. Not affected are products with lot numbers 13032 and higher. Vital Signs has notified all customers with affected units through an Urgent Medical Device Correction letter, which alerts users of the concern and safety instructions. Vital Signs is also following up with all customers and will replace all affected units at no cost to customers.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm380128.htm

    Rx Formulations

    The FDA is alerting healthcare providers, hospital supply managers, and pharmacists that 2 to 3 millimeter, irregularly shaped, floating matter was observed in calcium gluconate injection from an intact, unused vial produced at Rx Formulations. The Company informed the FDA that it is recalling products marketed as sterile that were made in the same area of the facility as the contaminated product. The following products, compounded in Hood #2 between 11/7/2013 and 12/11/2013, are subject to the recall by Rx Formulations: Calcium Gluconate 10%, Magnesium Sulfate, Potassium Phosphates 4.4 mEq/ml, Oxytocin 10 Units/ml, Sodium Bicarbonate 8.4%, and Bupivacaine 3%. The FDA has not received any adverse event reports associated with calcium gluconate injection from Rx Formulations. The FDA asks healthcare providers and consumers to report adverse reactions or quality problems experienced with products made by Rx Formulations to the FDA’s MedWatch Adverse Event Reporting program.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm378580.htm


    Alexion Pharmaceuticals, Inc. is providing further information regarding a previously communicated voluntary recall of two lots of Soliris (eculizumab) Concentrated Solution for Intravenous Infusion. As stated on November 12, 2013, the two lots were found to contain visible particles. At that time, Alexion provided instructions to return any unused vials of Soliris from these two lots at the distributor level. Alexion is now providing the same instructions at the hospital/user level. Alexion and its distributors typically ship Soliris to healthcare providers in small quantities, which are timed to individual patient infusions, with the product being consumed before more is shipped. As product was last shipped on November 1, 2013, Alexion believes there is little, if any, inventory currently being held at the hospital or user level.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm378614.htm

    TRUEbalance and TRUEtrack Blood Glucose Meters

    Nipro Diagnostics, Inc. has announced that it is initiating a voluntary recall and replacement of a limited number of TRUEbalance and TRUEtrack Blood Glucose Meters distributed both inside and outside the United States. The company has determined that certain isolated TRUEbalance and TRUEtrack Blood Glucose Meters distributed in the United States have an incorrect factory-set unit of measure that displays the glucose result in mmol/L rather than mg/dL. If a consumer were not to notice the incorrect unit of measure, it is possible that the meter result could be read as a lower than expected blood glucose result. There are 501 affected TRUEbalance meters and 105 affected TRUEtrack meters that were distributed in the United States from September 2008 to May 2013. Nipro Diagnostics, Inc. has not received any reports of patient injuries or adverse events related to this recall.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm380679.htm

    FDA Alerts


    The FDA is requiring several new safety measures for the leukemia drug Iclusig (ponatinib) to address the risk of life-threatening blood clots and severe narrowing of blood vessels. Once these new safety measures are in place, the manufacturer of Iclusig is expected to resume marketing to appropriate patients. The required safety measures involve label changes to narrow the indication, provide additional warnings and precautions about the risk of blood clots and severe narrowing of blood vessels, revise recommendations about dosage and administration of Iclusig, and update the patient Medication Guide. The FDA is also requiring a risk evaluation and mitigation strategy. In addition, the manufacturer of Iclusig, ARIAD Pharmaceuticals, must conduct postmarket investigations to further characterize the drug’s safety and dosing.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm379554.htm

    Methylphenidate Products

    The FDA is warning that methylphenidate products, one type of stimulant drug used to treat attention deficit hyperactivity disorder, may in rare instances cause prolonged and sometimes painful erections known as priapism. Based on a recent review of methylphenidate products, the FDA updated drug labels and patient Medication Guides to include information about the rare but serious risk of priapism. Priapism appears to be more common in patients taking atomoxetine than in those taking methylphenidate products; however, because of limitations in available information, the FDA does not know how often priapism occurs in patients taking either type of product.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm378876.htm

    Nipple Aspirate Test

    Certain manufacturers are promoting the use of nipple aspirate tests as a stand-alone evaluation tool for screening and diagnosing breast cancer, claiming they are an alternative to biopsy or mammography. They also claim that a nipple aspirate test can detect pre-cancerous abnormalities and diagnose breast cancer before mammography with just a sample of a few cells. The FDA is concerned that women will believe these misleading claims about a nipple aspirate test and not get mammograms and/or other needed breast imaging tests or biopsies. This may lead to serious adverse health consequences. The FDA is alerting the public, including women and healthcare providers, that a nipple aspirate test is not a replacement for mammography, other breast imaging tests, or breast biopsy, and should not be used by itself to screen for or diagnose breast cancer. The FDA is not aware of any valid scientific data to show that a nipple aspirate test by itself is an effective screening tool for any medical condition, including the early detection of breast cancer or other breast disease. The FDA, other public health agencies, and national medical and professional societies agree that mammography is the most effective method for detecting breast cancer in its earliest, most treatable stages. These organizations include the American Cancer Society, the American College of Radiology, the Centers for Disease Control and Prevention, the National Cancer Institute, and the Society for Breast Imaging. The National Comprehensive Cancer Network 2013 guidelines state that the clinical utility of nipple aspiration is still being evaluated and it should not be used as a breast cancer screening technique.
    For more information, visit: www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm378389.htm

    OTC Sodium Phosphate Products

    The FDA is warning that using more than one dose in 24 hours of over-the-counter (OTC) sodium phosphate drugs to treat constipation can cause rare but serious harm to the kidneys and heart, and even death. OTC sodium phosphate drug products include oral solutions taken by mouth and enemas used rectally. Healthcare professionals should use caution when recommending an oral dose of these products for children 5 years and younger. The rectal form of these products should never be given to children younger than 2 years. The FDA has become aware of reports of severe dehydration and changes in the levels of serum electrolytes from taking more than the recommended dose of OTC sodium phosphate products, resulting in serious adverse effects on organs, such as the kidneys and heart, and in some cases resulting in death. Some individuals may be at higher risk for potential adverse events when the recommended dose of OTC sodium phosphate is exceeded. These individuals include young children; individuals older than 55 years; patients who are dehydrated; patients with kidney disease, bowel obstruction, or inflammation of the bowel; and patients who are using medications that may affect kidney function. These medications include diuretics; angiotensin converting enzyme inhibitors and angiotensin receptor blockers used to treat high blood pressure; and nonsteroidal anti-inflammatory drugs such as aspirin, ibuprofen, or naproxen.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm380757.htm