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  • FDA Drug Updates

    FDA New Approvals

    Alecensa

    Genentech announced that the FDA granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase-positive, metastatic non-small cell lung cancer who have progressed on or are intolerant to crizotinib. Learn more about Alecensa

    Bridion

    Merck announced that the FDA has approved Bridion (sugammadex) Injection 100mg/mL (equivalent to 108.8mg/mL sugammadex sodium) for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. Bridion is expected to be available in January 2016. Learn more about Bridion

    Cefotan

    Teligent, Inc. announced it has received approval of its supplemental new drug application from the FDA for Cefotan (cefotetan) for Injection. The company is working closely with their manufacturing partner to launch the product in early 2016. Learn more about Cefotan

    DigniCap Cooling System

    The FDA cleared for marketing in the US the DigniCap Cooling System to reduce the frequency and severity of alopecia during chemotherapy in breast cancer patients in which alopecia-inducing chemotherapeutic agents and doses are used. Learn more about the DigniCap Cooling System

    Docetaxel Injection, Non-Alcohol Formula

    Eagle Pharmaceuticals, Inc. announced that the FDA has approved Docetaxel Injection, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer. Learn more about Docetaxel Injection, Non-Alcohol Formula

    Extended-Release (ER) Chewable Tablet

    Tris Pharma, Inc. has announced that the FDA has approved the first-ever ER chewable tablet. ER chewable tablets are an extension of Tris' LiquiXR platform, a particulate based technology where hundreds of millions of tiny (about 100 microns) particles deliver drug over time. Learn more about the ER Chewable Tablet

    Fenix Continence Restoration System

    The FDA approved the Fenix Continence Restoration System to treat fecal incontinence in patients who are not candidates for, or have previously failed, medical or other surgical options. Learn more about the Fenix Continence Restoration System

    Otiprio

    Otonomy, Inc. announced that the FDA has approved Otiprio (ciprofloxacin otic suspension) for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement. Otiprio is expected to launch in the first quarter of 2016. Learn more about Otiprio

    Uptravi

    Actelion announced that the FDA has approved the use of the orally active, selective IP prostacyclin receptor agonist Uptravi (selexipag) for the treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and reduce the risk of hospitalization for PAH. Actelion expects Uptravi to become available to patients in the US in early January 2016. Learn more about Uptravi

    Vistogard

    Wellstat Therapeutics Corporation announced that the FDA has approved Vistogard (uridine triacetate) for emergency treatment of adult and pediatric patients following an overdose of the chemotherapy agents 5-fluorouracil (5-FU) or capecitabine regardless of the presence of symptoms, or to treat patients who exhibit early-onset, severe or life-threatening toxicity affecting the cardiac or central nervous system, and/or early-onset, unusually severe adverse reactions within 96 hours after the end of treatment with 5-FU or capecitabine. Learn more about Vistogard

    Zurampic

    AstraZeneca announced that the FDA has approved Zurampic (lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid levels with an XOI alone. Learn more about Zurampic

    FDA New Indications

    Gardasil 9

    Merck announced that the FDA approved an expanded age indication for Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, to now include use in males 16 through 26 years of age, for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. Gardasil 9 is already approved for use in boys 9 through 15 years of age for the prevention of these diseases. Gardasil 9 is also approved for use in girls and young women 9 through 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV 16, 18, 31, 33, 45, 52, and 58, precancerous or dysplastic lesions caused by HPV 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. Learn more about Gardasil 9

    Keytruda

    Merck announced that the FDA has approved an expanded indication for Keytruda (pembrolizumab), an anti-programmed death receptor-1 therapy, to include the first-line treatment of patients with unresectable or metastatic melanoma. This approval marks the second FDA-approved indication in advanced melanoma for Keytruda. Learn more about Keytruda

    LifeVest Wearable Cardioverter Defibrillator

    The FDA approved a new indication for the LifeVest wearable cardioverter defibrillator. The LifeVest is approved for certain children who are at risk for sudden cardiac arrest, but are not candidates for an implantable defibrillator due to certain medical conditions or lack of parental consent. The device was first approved in 2001 for patients 18 years of age and older. Later models of the device were approved for patients 18 years of age and older in 2002, 2006, and 2009. Learn more about LifeVest wearable cardioverter defibrillator

    Xeomin

    Merz North America, US affiliate of the global Merz Pharma Group, announced that Xeomin (incobotulinumtoxinA) has received FDA approval for the treatment of upper limb spasticity in adult patients. Xeomin was first approved by the FDA in August 2010 for the treatment of adults with cervical dystonia and blepharospasm. Learn more about Xeomin

    XSTAT 30

    The FDA cleared the use of the XSTAT 30 wound dressing, an expandable, multi-sponge dressing used to control severe, life-threatening bleeding from wounds in areas that a tourniquet cannot be placed (such as the groin or armpit) in battlefield and civilian trauma settings. The clearance expands the device’s indication from use by the military only to use in adults and adolescents in the general population. Learn more about XSTAT 30

    FDA Recalls

    Apexxx

    Nuway Distributors LLC is voluntarily recalling all lots of Apexxx tablets to the consumer level. FDA analysis found Apexxx to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction, making this a tainted dietary supplement and unapproved drug. All lots of Apexxx are included in this recall sold in 2014 to June 2015. Learn more about Apexxx

    Baxter IV Solutions

    Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified as a result of a customer complaint. The lots being recalled were distributed to customers and distributors in the US between June 6, 2015 and December 16, 2015. Learn more about Baxter IV solutions

    Bee Extremely Amazed Weight Loss Products

    Bee Extremely Amazed LLC is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein. The affected products were sold nationwide between 4/29/2014 and 12/17/2015. Learn more about Bee Extremely Amazed weight loss products

    Chariot Guiding Sheath

    Boston Scientific has voluntarily recalled the Chariot Guiding Sheath globally. The recall affects all UPNs of the Chariot Guiding Sheaths. These devices are intended for the introduction of interventional devices during peripheral vascular procedures. The recall was initiated on November 19, 2015 due to the risk of shaft separation. Learn more about the Chariot Guiding Sheath

    Etest PIP/TAZO/CON-4 PTC 256

    BioMérieux recalled the Etest PIP/TAZO/CON-4 PTC 256 because the test results from the affected product may indicate that antibiotic therapy using PIP/TAZO could stop or slow the growth of certain bacteria when it may not actually be effective in treating those bacteria. This error may result in inappropriate treatment of a patient’s infection and could cause serious patient health consequences, including increased time in the hospital, unnecessary tests or procedures, treatment failure, sepsis, and even death. This recall includes all affected products with manufacturing dates December 20, 2012 to October 23, 2015, and distribution dates January 24, 2013 to November 9, 2015. Learn more about Etest PIP/TAZO/CON-4 PTC 256

    Evita V500 and Babylog VN500 Ventilators

    Dräger is recalling the PS500 battery power supply because a software issue causes shorter than expected battery run times. The software issue with the power supply also prevents the appropriate alarm from sounding 5 minutes before the battery runs out of power and the device shuts down. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death. The recalled device is the optional PS500 battery power supply for Dräger Evita V500 and Babylog VN500 ventilators, manufactured from June 1, 2011 to October 30, 2015 and distributed from June 1, 2011 to October 30, 2015.  Learn more about Evita V500 and Babylog VN500 ventilators

    Fuel Up Plus and Fuel High Octane

    Reesna Inc. is voluntarily recalling all lots of Fuel Up Plus and Fuel Up High Octane particularly distributed in August 2015 due to containing undeclared hydroxythiohomosildenafil, an analogue of sildenafil. Fuel Up is marketed as a dietary supplement sexual enhancer for men. The product was sold to distributors and retail stores nationwide and via internet sales. Learn more about Fuel Up Plus and Fuel High Octane

    La’ Trim Plus, Jenesis, and Oasis

    BeeXtreme LLC is recalling all lots of La' Trim Plus, Jenesis, and Oasis products from the market. Recent Analysis by the FDA has found undeclared sibutramine and phenolphthalein in the dietary supplement “La’ Trim Plus,” “Oasis,” and “Jenesis.” The recall includes all lots and expiration dates. Learn more about La’ Trim Plus, Jenesis, and Oasis

    Magnesium Sulfate in Water for Injection

    Hospira, Inc. announced a voluntary recall of one lot of Magnesium Sulfate in Water for Injection (0.325mEq Mg**/mL) 40mg/mL 2g total, 50mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling. The product has a barcode identifying the product contents on both the overwrap and on the primary container. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP Units/1000mL in 0.9% Sodium Chloride Injection. Learn more about Magnesium Sulfate in Water for Injection

    Norepinephrine Bitartrate Added to 0.9% Sodium Chloride in 250mL Viaflex Bag

    PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. They have received complaints from hospitals for products that have been found to exhibit a slight discoloration in the admixture. Learn more about Norepinephrine Bitartrate added to 0.9% Sodium Chloride in 250mL Viaflex Bag

    Perseus A500 Anesthesia Workstation

    Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. This could cause patients to suffer serious adverse health consequences, including injury or death. The recall includes all Draeger Perseus A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015 with distribution dates of February 1, 2015 to September 30, 2015. Learn more about the Perseus A500 anesthesia workstation

    Pink Bikini Dietary Supplement

    Lucy's Weight Loss System is voluntarily recalling all lots of Pink Bikini White powder capsules, 30 white (750mg per capsule) to the consumer level. Pink Bikini has been found positive for diclofenac after FDA sampling and testing. The affected Pink Bikini and lots include the following expiration date: 7/30/2017. Learn more about Pink Bikini dietary supplement

    Smart Lipo

    SmartLipo365 is voluntarily recalling all lots of Smart Lipo (800, 900, 950mg) capsules, to the consumer level. The FDA's analysis found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. Learn more about Smart Lipo

    FDA Alerts

    Baclofen

    The FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) may be at risk for contamination with particulates and should not be used to compound sterile injectable drugs. Learn more about Baclofen

    Customed, Inc. Surgical Convenience Packs and Trays

    The FDA is warning healthcare providers and staff at healthcare facilities not to use Customed convenience packs and trays for any surgical procedures. The integrity, safety, and efficacy of these products cannot be assured because adequate testing has not been completed to assure the sterility of the products, that endotoxin and ethylene oxide levels are within safe limits, that package integrity can withstand stresses during transport, and that the products will be effective up to their expiration dates. Learn more about Customed, Inc. surgical convenience packs and trays

    Dietary Supplements Containing Kratom

    The FDA announced that US Marshals, at the agency’s request, seized nearly 90,000 bottles of dietary supplements labeled as containing kratom. The product, manufactured for and held by Dordoniz Natural Products LLC, is marketed under the brand name RelaKzpro and is worth more than $400,000. Learn more about dietary supplements containing kratom

    ED-530XT Duodenoscopes

    FUJIFILM Medical Systems, U.S.A., Inc. (Fuji) issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the Agency’s expectations. The FDA recommends that facilities using Fuji’s ED-530XT duodenoscope train staff on the new instructions and implement them as soon as possible. Learn more about ED-530XT duodenoscopes

    Noxafil

    The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors. To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose. Direct mg for mg substitution of the two formulations can result in drug levels that are lower or higher than needed to effectively treat certain fungal infections. Learn more about Noxafil

    Rosiglitazone-Containing Diabetes Medicines

    The FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. Learn more about rosiglitazone-containing diabetes medicines

    Surgical Mesh to Repair Pelvic Organ Prolapse

    The FDA issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP. The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. Learn more about surgical mesh to repair POP

    Tianjin Drug Shipments

    The FDA is alerting drug compounders and manufacturers that drug shipments from Tianjin, China may be at risk of chemical contamination. The FDA increased surveillance of drug shipments following two massive explosions at Tianjin Dongjiang Port Ruihai International Logistics Co., a chemical warehouse, in August 2015. The increased surveillance resulted in the detection of hydrogen cyanide contamination in two shipments of drugs from Tianjin Tianyao Pharmaceuticals Co., Ltd. Located approximately 30 kilometers (18 miles) from the explosion site. Learn more about Tianjin drug shipments