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  • FDA Drug Updates

    FDA New Approvals

    Affymetrix CytoScan Dx Assay

    The FDA has authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes. The FDA reviewed the Affymetrix CytoScan Dx Assay through its de novo classification process, a regulatory pathway for some novel low-moderate-risk medical devices. The device should not be used for stand-alone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer. The test results should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate. Affymetrix CytoScan Dx Assay is manufactured by Affymetrix, Inc.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm382179.htm

    CoreValve System

    Medtronic, Inc. has announced the FDA approval of the self-expanding transcatheter CoreValve System for severe aortic stenosis patients who are too ill or frail to have their aortic valves replaced through traditional open-heart surgery. The FDA granted approval of the CoreValve device without an independent device advisory panel review after reviewing the clinical outcomes in the Extreme Risk Study of the CoreValve U.S. Pivotal Trial, which demonstrated that the CoreValve System is safe and effective with high rates of survival and some of the lowest rates of stroke and valve leakage reported.
    For more information, visit: www.newsroom.medtronic.com/phoenix.zhtml?c=251324&p=irol-newsArticle&ID=1891769&highlight


    The FDA has approved Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24-hour sleep-wake disorder (“non-24”) in totally blind individuals. Non-24 is a chronic circadian rhythm disorder in the blind that causes problems with the timing of sleep. Hetlioz also received orphan-product designation by the FDA because it is intended to treat a rare disease or condition. Hetlioz is manufactured by Vanda Pharmaceuticals, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm384092.htm

    ReSure Sealant

    The FDA has approved the first gel sealant for use in stopping fluid from leaking through the incision in a patient’s cornea after cataract surgery with intraocular lens placement in adults. Prior to this approval, stitches were the only option for closing a leaking corneal incision after cataract surgery. The ReSure Sealant kit comes as two liquid solutions that the surgeon mixes together just prior to sealing the incision. ReSure Sealant is manufactured by Ocular Therapeutix. The company will perform a post-approval study evaluating at least 4,857 patients undergoing clear corneal cataract surgery to gather further information on the incidence of adverse events associated with ReSure Sealant.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm381139.htm

    FDA New Formulations


    Merck has announced that the FDA recently approved Isentress for oral suspension, a new pediatric formulation of Merck’s integrase inhibitor. With this approval, Isentress is now indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients four weeks of age and older. The oral suspension may be used in patients as young as four weeks of age, weighing at least 3 kg to less than 20 kg. The safety and efficacy of Isentress have not been established in infants less than four weeks of age. Formulations of Isentress for specific populations now include oral suspension, chewable tablets, and film-coated tablets.
    For more information, visit: www.mercknewsroom.com/news-release/prescription-medicine-news/merck-receives-fda-approval-isentress-raltegravir-pediatric-

    Pennsaid 2%

    Nuvo Research Inc. has announced that the FDA has approved Mallinckrodt’s New Drug Application for Pennsaid (diclofenac sodium topical solution) 2% w/w (Pennsaid 2%). Pennsaid 2% is a follow-on product to original Pennsaid (diclofenac sodium topical solution) 1.5% w/w (Pennsaid 1.5%), which has been marketed by Mallinckrodt in the U.S. since 2010. Pennsaid 2% will be the first twice per day dosed topical NSAID available in the U.S. for the treatment of the pain of osteoarthritis of the knee. Nuvo has licensed the U.S. sales and marketing rights for both Pennsaid 1.5% and Pennsaid 2% to Mallinckrodt.
    For more information, visit: www.nuvoresearch.com/documents/press_releases/2014-01-17_Nuvo_Announces_FDA_Approval_Pennsaid_2_Percent.pdf

    FDA New Dosing

    Copaxone 40mg/mL

    Teva Pharmaceutical Industries Ltd. has announced that the FDA has approved the Company’s supplemental new drug application for three-times-a-week Copaxone 40mg/mL, a new dose of Copaxone. This new formulation will allow for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of multiple sclerosis. In addition to the newly approved dose, daily Copaxone 20mg/mL will continue to be available. Three-times-a-week Copaxone 40mg/mL is available for shipping to distribution outlets immediately, and will be available to patients within days.
    For more information, visit: www.news.tevausa.com/phoenix.zhtml?c=251945&p=irol-newsArticle&ID=1894511&highlight

    FDA Recalls

    Covidien, Puritan Bennett 840 Series Ventilator

    The FDA has notified healthcare professionals of a Class I recall of the Covidien, Puritan Bennett 840 Series Ventilator. Due to a software problem, a diagnostic code (XB0069) may be triggered. This causes the ventilator to stop functioning, triggering the safety alarm and causing the patient to suddenly be required to breathe on his or her own. This product may cause serious adverse health consequences, including death. The affected Software Part Number is 4-070212-85, Revision AB-AG, Manufactured: April 30, 1998 to March 12, 2010 and Distributed: August 1, 2008 to October 31, 2010. On December 16, 2013, Covidien sent an Urgent Medical Device Voluntary Field Correction letter to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to continue using their Puritan Bennett 840 ventilators until they are able to install the software update outlined in the letter.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381236.htm


    Merck is voluntarily recalling all lots of Liptruzet (ezetimibe and atorvastatin) 10/10mg, 10/20mg, 10/40mg, and 10/80mg tablets in the U.S., including Puerto Rico, due to packaging defects. Merck is recalling from wholesalers all lots of Liptruzet that have been distributed since the product was introduced in May 2013. Some of the outer laminate foil pouches may allow in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product. The likelihood of the packaging defects decreasing the effectiveness of Liptruzet on a patient’s lipid profile or negatively impacting the safety of the product is remote. The decision to recall Liptruzet was not based on any reported adverse experiences or product quality complaints. The recall will deplete all available supply in the U.S., and stock-outs are expected. The two active ingredients remain available: Zetia (ezetimibe), from Merck, and atorvastatin is available as a generic from multiple manufacturers. The recall does not affect any other products manufactured by Merck.
    For more information, visit: www.mercknewsroom.com/news/company-statements/merck-voluntarily-recalls-all-lots-liptruzet-united-states-wholesalers-due-0

    Rohto Eye Drops

    The Mentholatum Company announced a voluntary recall of Rohto Arctic, Rohto Ice, Rohto Hydra, Rohto Relief, and Rohto Cool eye drops. The recall was initiated due to a manufacturing review at the production facility in Vietnam involving sterility controls. To date (as of the January 16, 2014 press release), there has been no evidence indicating that product does not meet specifications. The products are sold nationwide over-the-counter at pharmacies and retail stores. This recall includes only lots of product that were manufactured in Vietnam. The lot numbers for products made in Vietnam will include the letter "V," for example, "Lot 3E1V," and will be located on the bottom panel of the carton, and on the bottom of the eye drop bottle.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm382097.htm

    TRUFILL n-BCA Liquid Embolic System

    Codman Neuro has announced that the FDA has classified the recently initiated medical device correction notice related to the TRUFILL n-BCA Liquid Embolic System as a Class I recall. TRUFILL n-BCA is indicated for embolization of cerebral arteriovenous malformations when presurgical devascularization is desired. The use of incorrectly mixed product can result in the liquid mixture solidifying too slowly in unintended areas, which may lead to embolization or reflux into arteries and pulmonary vessels. This could result in significant impact to the patient, including neurological deficits, pulmonary emboli, and possibly death. In October 2013, Codman Neuro identified an incorrect statement in the product's Instructions For Use (IFU) that described suggested mixing ratios for use in certain treatment conditions, informed the FDA and other regulatory authorities, and issued a corresponding correction notice to inform customers in the U.S., Costa Rica, Puerto Rico, and Russia. The error was identified through routine internal procedures. The product is not being removed from the market. The company is informing physicians of this incorrect statement and updating the product's IFU.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm382496.htm

    t:slim Insulin Cartridges

    Tandem Diabetes Care announced that it is initiating a voluntary recall of specific lots of insulin cartridges that are used with the t:slim Insulin Pump. The affected cartridges may be at risk for leaking. A cartridge leak could potentially result in the device delivering too much or too little insulin, which can lead to a serious adverse event. Affected lots were shipped on or after December 17, 2013. The affected lots represent approximately 4,746 boxes of cartridges (10 cartridges per box). Customers should discontinue using cartridges labeled with the affected lots.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381606.htm

    FDA Alerts


    The FDA is recommending that healthcare professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325mg of acetaminophen per tablet, capsule, or other dosage unit. There are no available data to show that taking more than 325mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death. Cases of severe liver injury with acetaminophen have occurred in patients who: took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period; took more than one acetaminophen-containing product at the same time; or drank alcohol while taking acetaminophen products. In January 2011, the FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325mg in each tablet or capsule by January 14, 2014. The FDA will address OTC acetaminophen products in another regulatory action.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm381650.htm

    Testosterone Products

    The FDA is investigating the risk of stroke, heart attack, and death in men taking FDA-approved testosterone products. The FDA has been monitoring this risk and decided to reassess this safety issue based on the recent publication of two separate studies that each suggested an increased risk of cardiovascular events among groups of men prescribed testosterone therapy. The FDA is providing this alert while it continues to evaluate the information from these studies and other available data, and will communicate its final conclusions and recommendations when the evaluation is complete. At this time, the FDA has not concluded that FDA-approved testosterone treatment increases the risk of stroke, heart attack, or death.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm383904.htm