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  • FDA Drug Updates

    FDA New Approvals

    Addyi

    Sprout Pharmaceuticals, Inc. announced that the FDA has granted approval of Addyi (flibanserin 100mg), a once-daily, non-hormonal pill for the treatment of acquired, generalized hypoactive sexual desire disorder in premenopausal women. Addyi is anticipated to be available by October 17, 2015. Learn more about Addyi

    Dexcom G5 Mobile Continuous Glucose Monitoring (CGM) System

    Dexcom announced that the FDA has approved the Dexcom G5 Mobile CGM System for both adults and children as young as 2 years of age. With wireless Bluetooth technology built into the device transmitter, the G5 Mobile CGM System sends glucose data directly to a smartphone, freeing users from the need to carry a separate receiver. Learn more about the Dexcom G5 Mobile CGM System

    Durlaza

    New Haven Pharmaceuticals, Inc. announced that the FDA has approved Durlaza (aspirin), 24-hour, extended-release capsules, (162.5mg) for the secondary prevention of stroke and acute cardiac events, including myocardial infarction. Learn more about Durlaza

    Eko Core

    Eko Devices has received FDA clearance to launch Eko Core, a next generation digital stethoscope. Eko Core is the only stethoscope on the market to wirelessly stream heart sounds to a HIPAA-compliant smartphone app and the first to integrate heart sounds directly into the patient’s electronic health record. Learn more about Eko Core

    Keveyis

    Taro Pharmaceutical Industries Ltd. announced that the FDA has approved Keveyis (dichlorphenamide) 50mg tablets for the treatment of primary hyperkalemic and hypokalemic periodic paralysis, a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. Taro expects Keveyis will be available for patients during the third quarter of 2015. Learn more about Keveyis

    Repatha

    Amgen announced that the FDA has approved a new cholesterol-lowering medication, Repatha (evolocumab) Injection. Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9, a protein that reduces the liver's ability to remove low-density lipoprotein cholesterol (LDL-C) from the blood. Repatha is indicated as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with heterozygous familial hypercholesterolemia or clinical atherosclerotic cardiovascular disease, who require additional lowering of LDL-C; and as an adjunct to diet and other LDL-lowering therapies for the treatment of patients with homozygous familial hypercholesterolemia, who require additional lowering of LDL-C. Learn more about Repatha

    ReShape Integrated Dual Balloon System

    ReShape Medical announced that the FDA has approved the ReShape Integrated Dual Balloon System, a non-surgical weight loss procedure for people with mild to moderate obesity. The ReShape Procedure provides a new option for adults with a BMI of 30–40 and a related health condition who have not succeeded at diet and exercise alone, and do not want or do not qualify for bariatric surgery. Learn more about the ReShape Integrated Dual Balloon System

    SIC 8000

    Cosmo Pharmaceuticals announced that the FDA has approved its request for marketing authorization of SIC 8000, its submucosal injectable composition. The SIC is an injectable liquid composition for use as a submucosal injection agent during endoscopic mucosal resection, endoscopic mucosal dissection, and polypectomy procedures in the gastrointestinal tract. Learn more about the SIC 8000

    Synjardy

    The FDA has approved Synjardy (empagliflozin and metformin HCl) tablets, from Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company, for the treatment of adults with type 2 diabetes. Learn more about Synjardy

    Varubi

    Tesaro, Inc. announced that the FDA has approved Varubi (rolapitant) in combination with other antiemetic agents in adults for the prevention of delayed nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy. Varubi is a selective and competitive antagonist of human substance P/neurokinin 1 receptors. Learn more about Varubi

    Ximino

    Sun Pharmaceutical Industries Ltd. (Sun Pharma) announced that the FDA has approved its Supplemental New Drug Application for Ximino (minocycline HCl) extended-release capsules 45mg, 90mg, and 135mg. Ximino extended-release capsules are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. Sun Pharma expects Ximino extended-release capsules to be available for patients during the fourth quarter of 2015. Learn more about Ximino

    Xuriden

    Wellstat Therapeutics Corporation announced that the FDA granted marketing approval for Xuriden (uridine triacetate), a pyrimidine analogue for uridine replacement indicated for the treatment of hereditary orotic aciduria. Wellstat anticipates that Xuriden will be commercially available in early 2016. Learn more about Xuriden

    FDA New Formulations

    Onsolis

    BioDelivery Sciences International, Inc. announced the approval by the FDA of a Supplemental New Drug Application for a new formulation of Onsolis (fentanyl buccal soluble film) CII for the management of breakthrough pain in patients with cancer who are opioid tolerant. The new formulation was submitted to address previously announced appearance-related changes. Learn more about Onsolis

    FDA New Indications

    Adcetris

    Seattle Genetics, Inc. announced that the FDA has approved Adcetris (brentuximab vedotin) for the treatment of patients with classical Hodgkin lymphoma (HL) at high risk of relapse or progression as post-autologous hematopoietic stem cell transplantation consolidation. This is the third indication for Adcetris, which was granted accelerated FDA approval in August 2011 for two other indications: (1) treatment of HL patients who fail autologous transplant or who fail at least two prior multi-agent chemotherapy regimens and are not autologous transplant candidates, and (2) treatment of systemic anaplastic large cell lymphoma patients who fail at least one prior multi-agent chemotherapy regimen. Learn more about Adcetris

    Brilinta

    AstraZeneca announced that the FDA has approved Brilinta (ticagrelor) tablets at a new 60mg dose to be used in patients with a history of heart attack beyond the first year. With this expanded indication, Brilinta is now approved to reduce the rate of cardiovascular death, myocardial infarction (MI), and stroke in patients with acute coronary syndrome or a history of MI. The new Brilinta 60mg tablet is expected to be available in pharmacies by the end of September 2015. Learn more about Brilinta

    Emend

    Merck announced that the FDA has approved a Supplemental New Drug Application for Emend (aprepitant) capsules, a substance P/neurokinin 1 receptor antagonist. With this expanded indication, Emend capsules are now approved for use in combination with other antiemetic agents in patients 12 years of age and older and patients less than 12 years who weigh at least 30kg (approximately 66 pounds) for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy including high-dose cisplatin, as well as for the prevention of nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy. Learn more about Emend

    OxyContin

    The FDA broadened the use of Purdue Pharma's analgesic OxyContin (oxycodone) to include patients aged 11 to 16 years who require daily, continuous, long-term opioid treatment to manage severe pain that is inadequately relieved by alternative therapies. Learn more about OxyContin

    Procysbi

    Raptor Pharmaceutical Corp. announced that the FDA approved the expanded use of Procysbi (cysteamine bitartrate) delayed-release capsules to treat children 2 to 6 years of age with nephropathic cystinosis. Procysbi is now approved for the treatment of nephropathic cystinosis in adult and in pediatric patients 2 years of age and older in the US. Learn more about Procysbi

    Promacta

    Novartis announced that the FDA has approved an expanded use for Promacta (eltrombopag) to include children 1 year of age and older with chronic immune thrombocytopenia who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy. The updated label also includes a new oral suspension formulation of Promacta that is designed for younger children who may not be able to swallow tablets. Promacta was approved by the FDA as a tablet formulation in June 2015 for children 6 years of age and older and in 2008 for use in adult patients with the same condition. Learn more about Promacta

    Wilate

    Octapharma USA announced the FDA has approved revised product labeling for Wilate (von Willebrand Factor/Coagulation Factor VIII Complex [Human]) to include prevention of excessive bleeding during and after minor and major surgery in adult and pediatric von Willebrand disease (VWD) patients. The newly approved product label expands the FDA license for Wilate, which formerly included only the treatment of spontaneous and trauma-induced bleeding episodes in patients with severe VWD, as well as patients with mild or moderate VWD in whom the use of desmopressin is known or suspected to be ineffective or contraindicated. Learn more about Wilate

    Zubsolv

    Orexo announced that the FDA has approved Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. Learn more about Zubsolv

    FDA Labeling Updates

    Sprycel

    Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, Inc. announced that the FDA has approved an update to the Sprycel (dasatinib) product labeling. The labeling now includes five-year efficacy and safety data in adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP) and seven-year data in CP Ph+ CML patients who are resistant or intolerant to prior therapy, including Gleevec (imatinib mesylate). Learn more about Sprycel

    Teflaro

    Allergan announced the FDA has approved the company's Supplemental New Drug Application to update the label for Teflaro (ceftaroline fosamil) for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSIs) and community-acquired bacterial pneumonia. The approved label contains new clinical data from two ABSSSI trials that included patients with baseline Staphylococcus aureus bacteremia. With this updated label, Teflaro also is now approved to be administered by intravenous infusion in five minutes to one hour in adult patients 18 years and older. Learn more about Teflaro

    FDA Recalls

    Alaris Medley Large Volume Pump (LVP) Frame Membrane

    The Alaris Medley LVP is an infusion pump used to deliver fluids such as nutrients and medications into a patient’s body in controlled amounts. The frame membranes are part of the pump that prevents fluids from leaking into internal components. Elite Biomedical Solutions discovered that the use of this part can result in over or under infusion of fluids to the patient with the potential to cause patient injury or death. Learn more about the Alaris Medley LVP Frame Membrane

    Alaris Syringe Pump

    An error in the Alaris Syringe Pump model number 8110 triggers a visual and audible alarm and causes the pump to stop supplying the infusion to the patient. Even when the user clears the error code 351.6740, the syringe pump does not respond to key presses until the product is detached and reattached to the PC unit used to program, monitor, and provide power to the syringe pump. Failure of the syringe module may result in a delay or interruption of therapy and can lead to serious patient injury or death. CareFusion has received 108 reports of the issue occurring. There have been no reports of permanent injury or death. Learn more about the Alaris Syringe Pump

    Beacon Tip Angiographic Catheters

    Cook Medical initiated a lot-specific voluntary recall of 2,239 lots of Beacon Tip Angiographic Catheters. Globally, 95,167 devices are subject to this recall. The products include specific versions and lot numbers of the Torcon NB Advantage Beacon Tip Catheters (Catalog Prefix HNBR5.0), Royal Flush Plus Beacon Tip High-Flow Catheters (Catalog Prefix HNR4.0), and Slip-Cath Beacon Tip Catheters (Catalog Prefix SCBR5.0). The Beacon Tip Angiographic Catheters in this recall were distributed between June 2013 and June 2015. Learn more about Beacon Tip Angiographic Catheters

    Evita V500 and Babylog VN500 Ventilator

    The battery (part of the PS500 Power Supply Unit) that powers the Evita V500 and Babylog VN500 Ventilators does not last as long as expected. The battery indicator light shows a sufficiently charged battery even when the battery is depleted. When the “battery low” and “battery depleted” alarms sound, the devices do not indicate how much time is left before the ventilator will shut down due to lack of power. Analysis by Dräger indicates that the battery should last approximately 30 minutes. If the power is lost, the 30-minute battery backup should last until the ventilator is connected to a main power supply. Learn more about the Evita V500 and Babylog VN500 Ventilator

    Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube

    Teleflex Medical has received customer complaints about the endobronchial tube’s double swivel connector. The connector may break or separate on the tube. If this happens, the device may leak, causing the patient to not receive enough oxygen (hypoxia) or experience respiratory distress. Learn more about the Hudson RCI Sheridan Sher-I-Bronch Endobronchial Tube

    Kaboom Action Strips and Lida Daidaihua

    Blue Square Market Inc. is recalling Kaboom Actions Strip 12 Pack and Lida Daidaihua to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients. Kaboom was found to contain sulfoaildenafil and Lida Daidaihua was found to contain sibutramine and phenolphthalein. Kaboom Actions Strips were marketed for men’s vitality and Lida Daidaihua was marketed for weight loss. Blue Square Market Inc. is notifying its customers by letter and is arranging for return and refund of all recalled products. Consumers who have purchased Kaboom Actions Strip 12 Pack from March 20, 2015 to July 7, 2015 or Lida Daidaihua from February 23, 2015 to May 7, 2015 should immediately discontinue use and return them to Blue Square Market Inc. for a full refund. Learn more about Kaboom Action Strips and Lida Daidaihua

    Medistat RX Sterile Drug Products

    The FDA is alerting healthcare professionals and patients of a voluntary recall of all non-expired drug products produced for sterile use and distributed nationwide by Medistat RX, LLC due to possible contamination. The recalled products were distributed between November 1, 2014 and September 3, 2015. Learn more about Medistat RX Sterile Drug Products

    Miracle Diet 30 and Miracle Rock 48

    The One Minute Miracle Inc. is voluntarily recalling all lots of Miracle Diet 30, capsules and Miracle Rock 48, capsules. Miracle Diet 30 has been found to contain undeclared phenolphthalein. All lots of Miracle Diet 30 through the expiration date of 04/15/2018 are affected. Miracle Rock 48 has been found to contain undeclared thiosildenafil. All lots of Miracle Rock 48 through the expiration date of 06/01/2018 are affected. Learn more about Miracle Diet 30 and Miracle Rock 48

    Novacare, LLC Dietary Supplements

    Novacare, LLC is voluntarily recalling all lots of select dietary supplements to the consumer level. Sample analysis by the FDA has revealed that these products contain the undeclared drug ingredient salicylic acid, making these unapproved new drugs. These products are marketed as dietary supplements aiding in weight loss, produced in capsule form, and were sold in bottles. These products were distributed nationwide to distributors. Learn more about Novacare, LLC Dietary Supplements

    OmniPod Insulin Management System

    Insulet Corporation initiated a lot-specific voluntary recall of 40,846 boxes (10 Pods per box) of the OmniPod (Pod) Insulin Management System. This field corrective action is due to the possibility that some of the Pods from these lots may have a higher rate of failure than Insulet's current manufacturing standards. This recall does not affect the OmniPod Personal Diabetes Manager. OmniPods from the affected lots were distributed to customers from December 2013 to March 2015. Learn more about the OmniPod Insulin Management System

    OxyTote Portable Oxygen Unit

    Western/Scott Fetzer Company received reports that when the OxyTote is mishandled or dropped, the oxygen cylinder may ignite, causing an internal flash fire and the canister to burst. The firm has received a total of two reports of incidents in which the device has malfunctioned, including one injury and one death. Learn more about the OxyTote Portable Oxygen Unit

    Prolotherapy with Phenol

    Hartley Medical is voluntarily recalling three lots of Prolotherapy with Phenol, Injectable to the hospital/user level due to non-sterility concerns. Prolotherapy with Phenol is used for neurolysis and is packaged in clear 5mL and/or 100mL sterile vials with labeling of the pharmacy and the drug. The affected Prolotherapy with Phenol lots include the following lot numbers and expiration dates: RX328690 Expires 12/1/2015, RX323132 Expires 10/6/2015, and RX321608 Expires 11/1/2015. Product was distributed in California and Nevada to pain clinics between May 15, 2015 and July 14, 2015. Learn more about Prolotherapy with Phenol

    Puritan Bennett 980 Ventilators

    When the ventilator is in neonatal Volume Control Plus mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician. If a patient does not receive the amount of air set on the machine, they may need to be removed from the ventilator and placed on a different system. The Puritan Bennett 980 Ventilator System provides constant breathing support for adults, children, and premature babies weighing at least 10.6 ounces. The ventilator is used in hospitals or during patient transport. Learn more about Puritan Bennett 980 Ventilators

    Refresh Lacri-Lube, Refresh P.M., FML 0.1%, and Blephamide 10%/0.2%

    Allergan announced that it is conducting a voluntary recall down to consumer level of specific lots of its Refresh Lacri-Lube 3.5g and 7g for dry eye, Refresh P.M. 3.5g for dry eye, FML (fluorometholone ophthalmic ointment) 0.1% (sterile ophthalmic ointment topical anti-inflammatory agent for ophthalmic use, 3.5g), and Blephamide (sulfacetamide sodium and prednisolone acetate ophthalmic ointment, USP) 10%/0.2% sterile topical ophthalmic ointment combining an antibacterial and a corticosteroid, 3.5g. Allergan chose to initiate this recall based on a small number of customer complaints that reported a small black particle at the time of use. This black particle, which is part of the cap, can be created by the action of unscrewing the cap from the aluminum tube, and potentially introduced into the product. Learn more about Refresh Lacri-Lube, Refresh P.M., FML 0.1%, and Blephamide 10%/0.2%

    Temodar

    Merck in conjunction with the US Consumer Product Safety Commission asked that all customers, including patients, inspect all bottles of Temodar (temozolomide) capsules and all bottles of Temozolomide capsules (generic) for potential cracks in the child-resistant bottle caps. Merck believes that approximately 1,100 bottles out of an estimated 276,000 distributed bottles of Temodar and Temozolomide capsules (generic) could potentially have cracked caps. Learn more about Temodar

    Ultimate Antioxidant Tablets

    VRVK Nutraceuticals, LLC is voluntarily recalling 3998 bottles of Ultimate Antioxidant Tablets Dietary Supplement, 120 count bottles, with Kelp Atlantic Powder that may contain crustacean shellfish, an undeclared allergen. This product also contains Hesperidin Complex 40%, Pancreatin Powder, and Pepsin, three ingredients that contain undeclared milk. People who have an allergy or severe sensitivity to milk and/or crustacean shellfish run the risk of serious or life-threatening allergic reaction if they consume these products. The lots in question are Lot Number 132415, expiration date 05/16 (1619 bottles sold), and Lot Number 141381, expiration date 06/17 (2379 bottles sold). Learn more about Ultimate Antioxidant Tablets

    FDA Alerts

    Becton-Dickinson (BD) Syringes

    The FDA is alerting healthcare professionals not to administer to patients compounded or repackaged drugs that have been stored in 3mL and 5mL syringes manufactured by BD unless there is no suitable alternative available. Preliminary information indicates that drugs stored in these syringes may lose potency over a period of time due to a possible interaction with the rubber stopper in the syringe. The company is alerting their customers not to use these syringes as a closed container system for compounded and repackaged drugs. Learn more about BD 3mL and 5mL Syringes

    The FDA is expanding its alert regarding compounded or repackaged drugs stored in BD general use syringes to include certain additional syringe sizes including 1mL, 10mL, 20mL, and 30mL BD syringes, and BD oral syringes Learn more about BD 1mL, 10mL, 20mL, and 30mL Syringes and BD Oral Syringes

    Dipeptidyl Peptidase-4 (DPP-4) Inhibitors for Type 2 Diabetes

    The FDA is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin, and alogliptin may cause joint pain that can be severe and disabling. The FDA has added a new Warning and Precaution about this risk to the labels of all medicines in this drug class, called DPP-4 inhibitors. Learn more about DPP-4 Inhibitors for Type 2 Diabetes

    Mammograms at Boston Diagnostic Imaging

    The FDA is alerting patients who had mammograms at Boston Diagnostic Imaging located in Orlando, Florida, anytime on or after May 13, 2013, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) conducted a clinical image review of mammograms performed by Boston Diagnostic Imaging between May 13, 2013 and May 13, 2015. The review was conducted after deficiencies were noted in the clinical cases that were submitted with the facility’s accreditation renewal application. The ACR revoked the facility’s application for mammography accreditation effective July 29, 2015. The FDA suspended the facility’s Mammography Quality Standards Act certificate on August 13, 2015 and directed the facility to cease performing mammography. Learn more about Mammograms at Boston Diagnostic Imaging

    Picato

    The FDA is warning about reports of severe allergic reactions and herpes zoster (shingles) associated with the use of Picato gel (ingenol mebutate). The FDA received reports of cases involving severe eye injuries and skin reactions associated with the application of Picato gel. Some cases were associated with Picato gel not being used according to the instructions for use on the label. As a result, the FDA is requiring changes to the label to warn about these new safety risks and to provide additional instructions on the safe and appropriate application of the product. Learn more about Picato

    Simponi Aria

    Janssen Biotech, Inc. announced the approval of an FDA Supplemental Biologics License Application for Simponi Aria (golimumab for infusion) for the treatment of moderately to severely active rheumatoid arthritis to include measures of physical and mental health reported by patients through the Medical Outcomes Study Short Form-36 (SF-36) questionnaire. According to the revised label, Simponi Aria, when administered in combination with methotrexate, improved patients’ physical and emotional well-being as measured by the SF-36 assessment. Learn more about Simponi Aria

    Treanda

    On March 10, 2015, the FDA issued a statement warning healthcare professionals not to use chemotherapy drug Treanda Injection (bendamustine HCl) [45mg/0.5mL or 180mg/2mL solution] with closed system transfer devices, adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene. As an update, the FDA is providing information on specific devices tested by Treanda manufacturer Teva Pharmaceuticals and found compatible with Treanda injection. Treanda is used to treat patients with chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. Learn more about Treanda