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  • FDA Drug Updates

    FDA New Approvals

    Afluria with PharmaJet’s Needle-Free Injector

    PharmaJet Inc. and bioCSL Inc. announced the FDA approval of the PharmaJet Stratis 0.5mL Needle-Free Jet Injector for delivery of Afluria in individuals aged 18 to 64 years. This is the first needle-free delivery system approved by the FDA for the administration of an inactivated influenza vaccine. The PharmaJet injector delivers the vaccine by means of a narrow, precise fluid stream that penetrates the skin in about one-tenth of a second.
    For more information, visit: pharmajet.com/fda-approves-afluria-influenza-vaccine-pharmajets-needle-free-injector/

    Arnuity Ellipta

    GlaxoSmithKline (GSK) announced that the FDA has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. Arnuity is not indicated for relief of acute bronchospasm. The approved doses are Arnuity Ellipta 100mcg and 200mcg. Arnuity Ellipta is administered once daily via the dry powder inhaler called Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio. Arnuity and Ellipta are trademarks of the GSK group of companies.
    For more information, visit: www.gsk.com/en-gb/media/press-releases/2014/gsk-receives-fda-approval-for-arnuity-ellipta-fluticasone-furoate-in-the-usa-for-the-treatment-of-asthma/


    Merck announced that the FDA has approved Belsomra (suvorexant) for adults with insomnia who have difficulty falling asleep and/or staying asleep. Belsomra is a highly selective antagonist for orexin receptors. Orexin is a neurotransmitter found in a specific part of the brain that can help keep a person awake. Belsomra is expected to be available in late 2014 or early 2015.
    For more information, visit: www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-belsomra-suvorexant-treatment-insomnia


    The FDA approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the Type 1 form of Gaucher disease, a rare genetic disorder. In patients with Gaucher disease Type 1, the drug slows down the production of the fatty materials by inhibiting the metabolic process that forms them. Cerdelga is manufactured by Genzyme.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm410585.htm


    The FDA has approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain kinds of abnormal growths that may be cancers such as colon cancer or precursors to cancer. Cologuard is manufactured by Exact Sciences.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409021.htm

    Ferric Citrate

    Keryx Biopharmaceuticals, Inc. announced that the FDA approved Ferric Citrate (formerly known as Zerenex) for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis.
    For more information, visit: investors.keryx.com/phoenix.zhtml?c=122201&p=irol-newsArticle&ID=1964304&highlight

    Flexbumin 5%

    Baxter International Inc. has announced that the FDA has approved Flexbumin [Albumin (Human)], USP, 5% Solution. Flexbumin 5% is indicated for hypovolemia, hypoalbuminemia due to general causes, burns, and in patients undergoing cardiopulmonary bypass surgery.
    For more information, visit: www.baxter.com/press_room/press_releases/2014/08_04_14_flexbumin.html


    Janssen Pharmaceuticals, Inc. announced the FDA has approved Invokamet, a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet, for the treatment of adults with type 2 diabetes. Invokamet provides the clinical attributes of Invokana (canagliflozin), the first sodium glucose co-transporter 2 inhibitor available in the U.S., together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes. Invokamet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications.
    For more information, visit: www.janssenpharmaceuticalsinc.com/assets/INVOKAMET%20FDA%20Approval%20Release.pdf


    The FDA granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs. Keytruda is the first approved drug that blocks a cellular pathway known as PD-1, which restricts the body’s immune system from attacking melanoma cells. Keytruda is intended for use following treatment with ipilimumab, a type of immunotherapy. For melanoma patients whose tumors express a gene mutation called BRAF V600, Keytruda is intended for use after treatment with ipilimumab and a BRAF inhibitor, a therapy that blocks activity of BRAF gene mutations.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm412802.htm


    The FDA has approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections. Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species, and Enterococcus faecalis. Orbactiv is administered intravenously. Orbactiv is marketed by The Medicines Company.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm408475.htm


    Biogen Idec announced that the FDA has approved Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS). Plegridy, the only pegylated beta interferon approved for use in RMS, is dosed once every two weeks and can be administered subcutaneously with the Plegridy Pen, a new, ready-to-use autoinjector, or a prefilled syringe.
    For more information, visit: www.biogenidec.com/press_release_details.aspx?ID=14712&Action=1&NewsId=2368&M=NewsV2&PID=61997

    Prestige LP Cervical Disc

    The FDA has approved the Prestige LP Cervical Disc. The Prestige LP Cervical Disc is intended for people who have stopped growing (skeletally mature patients) to replace a cervical disc (from C3-C7) following the removal of a diseased or bulging disc. The Prestige LP Cervical Disc is manufactured by Medtronic Sofamor Danek USA, Inc.
    For more information, visit: www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm408505.htm


    ViiV Healthcare announced that the FDA has approved Triumeq (abacavir 600mg, dolutegravir 50mg, and lamivudine 300mg) tablets for the treatment of HIV-1 infection. Triumeq is ViiV Healthcare’s first dolutegravir-based fixed-dose combination, offering many people living with HIV the option of a single-pill regimen that combines the integrase strand transfer inhibitor dolutegravir with the nucleoside reverse transcriptase inhibitors abacavir and lamivudine.
    For more information, visit: www.gsk.com/en-gb/media/press-releases/2014/viiv-healthcare-receives-fda-approval-for-triumeq-abacavir-dolutegravir-and-lamivudine-a-new-single-pill-regimen-for-the-treatment-of-hiv-1-infection/

    XVIVO Perfusion System with STEEN Solution

    The FDA approved the XVIVO Perfusion System with STEEN Solution, a device for preserving donated lungs that do not initially meet the standard criteria for lung transplantation but may be transplantable if there is more time to observe and evaluate the organ’s function to determine whether the lung is viable for transplantation. The XVIVO Perfusion System with STEEN Solution is manufactured by XVIVO Perfusion, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm409488.htm

    FDA New Indications


    Roche has announced that the FDA approved Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. Avastin is the first biologic medicine approved in combination with chemotherapy to help women with this type of cancer live longer than with chemotherapy alone.
    For more information, visit: www.roche.com/media/media_releases/med-cor-2014-08-15.htm


    Pfizer Inc. and Protalix BioTherapeutics, Inc. announced that the FDA approved Elelyso (taliglucerase alfa) for injection for pediatric patients. Elelyso is therefore now indicated for long-term enzyme replacement therapy for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.
    For more information, visit: www.pfizer.com/news/press-release/press-release-detail/pfizer_and_protalix_biotherapeutics_announce_fda_approval_of_pediatric_indication_for_elelyso_taliglucerase_alfa_for_injection_for_intravenous_use_for_the_treatment_of_type_1_gaucher_disease


    Bristol-Myers Squibb Company and Pfizer Inc. announced that the FDA has approved a Supplemental New Drug Application for Eliquis for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and for the reduction in the risk of recurrent DVT and PE following initial therapy.
    For more information, visit: www.pfizer.com/news/press-release/press-release-detail/u_s_fda_approves_eliquis_apixaban_for_the_treatment_of_deep_vein_thrombosis_dvt_and_pulmonary_embolism_pe_and_for_the_reduction_in_the_risk_of_recurrent_dvt_and_pe_following_initial_therapy


    GlaxoSmithKline announced that the FDA has approved a Supplemental New Drug Application for the once-daily use of Promacta (eltrombopag) in patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy.
    For more information, visit: www.gsk.com/en-gb/media/press-releases/2014/gsks-promacta-eltrombopag-receives-fda-approval-of-an-additional-indication/


    UCB announced that the FDA has approved a Supplemental New Drug Application for Vimpat (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older. This is a new indication for Vimpat, which is already approved in the U.S. as adjunctive treatment for partial-onset seizures in patients in this age group. This new indication means that adults with partial-onset seizures can be initiated on Vimpat monotherapy, and patients already on an anti-epileptic drug can be converted to Vimpat monotherapy. UCB also announced that the FDA has approved a new single loading dose administration option for all formulations of Vimpat, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
    For more information, visit: ucbusa.presscentre.com/News/New-indication-for-VIMPAT-lacosamide-UCB-s-anti-epileptic-drug-approved-by-FDA-as-monotherapy-in-4a1.aspx


    Iroko Pharmaceuticals, LLC, a global specialty pharmaceutical company dedicated to advancing the science of analgesia, announced the FDA has approved Zorvolex (diclofenac) capsules, a nonsteroidal anti-inflammatory drug for the management of osteoarthritis pain. This marks the second indication for Zorvolex, approved by the FDA in October 2013 for the treatment of mild to moderate acute pain in adults.
    For more information, visit: www.iroko.com/press-releases/iroko-pharmaceuticals-gains-fda-approval-of-zorvolex-for-management-of-osteoarthritis-pain/

    FDA First Time Generics

    Generic Klor-Con Extended-Release Tablets

    Mylan Inc. announced that it has launched Potassium Chloride Extended-Release Tablets USP, 8mEq (600mg) and 10mEq (750mg), which is the generic version of Upsher-Smith's Klor-Con. Mylan received final approval from the FDA for its Abbreviated New Drug Application for this product, which is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis; in digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. Mylan has begun shipping this product.
    For more information, visit: www.mylan.com/news/press-releases/item?id=123244

    Generic Megace ES

    TWi Pharmaceuticals, Inc. announced that it has received final approval from the FDA on its Abbreviated New Drug Application for megestrol acetate 125mg/mL oral suspension, the generic equivalent to Par Pharmaceutical's Megace ES.
    For more information, visit: www.twipharma.com/News/02/34

    FDA Recalls

    CloverSnare 4-Loop Vascular Retrieval Snare

    Cook Medical has initiated a recall of 696 of its CloverSnare 4-Loop Vascular Retrieval Snare devices. The device was recalled because of a potential for the loop to separate from the shaft, resulting in loss of device function, potential for embolization of snare fragments, and the potential need for intervention to retrieve the separated snare. Customers have been advised to return the recalled devices to Cook Medical. The recall affects products manufactured between August 2012 and August 2013 and distributed between March 8, 2013 and July 1, 2014.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm410687.htm

    Compounded Sterile Preparations

    Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all in-date compounded sterile preparations. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance. If the sterility of a compounded preparation is compromised, a patient is at risk for infection.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm412493.htm

    Cubicin (Daptomycin for Injection) 500mg in 10mL Single Use Vials

    Cubist Pharmaceuticals, Inc. announced a recall of certain lots of Cubicin (daptomycin for injection) to the user level due to the potential presence of glass particulate matter in vials produced by a contract manufacturer. The administration of a glass particulate, if present in an intravenous drug, poses a potential safety risk to patients such as a thromboembolism or life-threatening pulmonary emboli. Cubist is notifying customers by letter and phone. Those with an existing inventory of the product should determine whether they have product from the recalled lots, quarantine and discontinue distribution of the recalled lots of the product, and call Cubist.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408677.htm

    DePuy Synthes Craniomaxillofacial Distraction System

    The FDA notified healthcare professionals of a Class I recall of the DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies). Also called an External Mandibular Fixator And/Or Distractor and a Bone Plate. DePuy Synthes is recalling certain lots of the Craniomaxillofacial Distraction System because the device may reverse direction and lose the desired distraction distance after surgery. In all patient populations, failure of the device may result in the need for surgical intervention to replace the failed device.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm411891.htm

    Diamondback 360 Peripheral Orbital Atherectomy System

    The Diamondback 360 Peripheral Orbital Atherectomy System is a high-speed cutting tool inserted via a catheter through the skin into a patient’s blood vessel. The system is used to reestablish blood flow in narrowed arteries or arteriovenous dialysis shunts. It is intended for patients who are acceptable candidates for procedures to open up blocked blood vessels using catheters with balloons (percutaneous transluminal angioplasty). Cardiovascular Systems is recalling certain lots of the Diamondback 360 Peripheral Orbital Atherectomy Systems because they may contain defective saline sheaths that could fracture during use. If this happens, fragments of the sheath could possibly block the blood vessel under treatment or blood vessels further away (cause an embolism).
    For more information, visit: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm410449.htm

    Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II)

    Baxter International Inc. has announced it is voluntarily initiating a recall in the U.S. of two lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II) to the hospital/user level. The recall is being initiated due to the presence of oxidized stainless steel, garment fiber, and PVC particulate matter identified during the manufacturing process. This recall affects the following lots of Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose 5000mL (Ambu-Flex II container): NDC 0941-0457-05, Lots C940700 & C940841, Expiration May 31, 2016. The affected lots were distributed to customers between May 30, 2014 and July 9, 2014.
    For more information, visit: www.baxter.com/press_room/press_releases/2014/08_13_14_dianeal.html

    Gel-E Donut and Squishon 2

    FDA and Children’s Medical Ventures notified health professionals and their health delivery organizations of a class 1 recall of this product due to complaints about visible mold on the outer surface of Gel-E Donut and Squishon 2 gel-filled products. The detected mold was determined to be Cladosporium and Penicillium Fungi, commonly found molds. Cladosporium has been known to cause several different types of invasive infections, including skin, eye, sinus, and brain infections especially in vulnerable populations such as neonates, critically ill patients, and patients with an impaired or weakened immune system. Cladosporium and Penicillium Fungi can also cause difficulty in breathing or allergic reaction. These gel-filled products are used in hospitals, under the supervision of a caregiver, to support and cradle an infant’s head and/or body, help ease pressure caused by long periods of stillness, and allow for head movement while maintaining a supportive surface. The affected products were manufactured and distributed from July 1, 2012 to December 31, 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/ucm411089.htm

    IPM Wound Gel

    One lot of IPM Wound Gel may be contaminated with bacteria (Pseudomonas putida). Use of the affected product may cause serious adverse health consequences, including sepsis, limb loss, and death. IPM Wound Gel is used primarily in hospitals for wound care. It is used to care for leg ulcers, pressure ulcers, diabetic ulcers, surgical wounds (post-operative incisions and donor sites), dead, damaged, or infected tissue (debrided wounds), and second-degree wounds.
    For more information, visit: www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm409283.htm

    Sterile Convenience Surgical Packs

    Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. Consumers who have products should stop using the product lots manufactured from January 9, 2009 to May 19, 2014 and distributed from January 2009 to May 2014.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm411442.htm

    FDA Alerts

    Expression Injectable

    The FDA has become aware of adverse events associated with the unapproved use of the Expression product, hyaluronic acid that is packaged in a syringe, as a dermal filler. Events have included swelling, tenderness, firmness, lumps, bumps, bruising, pain, redness, discoloration, itching, and the development of hard nodules. Expression is listed with the FDA as an intranasal splint, and is intended to minimize bleeding and swelling and to prevent adhesions (sticking together) between the septum and the nasal cavity. The FDA issued a warning letter to Enhancement Medical LLC on June 4, 2014, advising the company of multiple quality system, correction/removal, and medical device reporting violations that were revealed during an inspection. The FDA recommends that healthcare providers stop using Expression by Enhancement Medical LLC as a subcutaneously administered substance and instead use the list of FDA approved fillers. In addition, patients who have received treatment with Expression as a dermal filler should be monitored for adverse events and referred for corrective treatment when appropriate.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm408113.htm