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  • FDA Drug Updates

    FDA New Approvals


    Chimerix, Inc. announced that brincidofovir has been provided for potential use in patients with Ebola virus disease. These requests were made by treating physicians. Emergency Investigational New Drug applications were granted by the FDA. Brincidofovir is an oral nucleotide analogue that has shown broad-spectrum in vitro antiviral activity against all five families of DNA viruses that affect humans, including viruses in the herpes virus family and adenovirus.
    For more information, visit: ir.chimerix.com/releasedetail.cfm?ReleaseID=874647


    The FDA has approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis. Esbriet acts on multiple pathways that may be involved in the scarring of lung tissue. Esbriet is manufactured for InterMune, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418991.htm

    inFlow Intraurethral Valve-Pump

    The FDA has allowed marketing of the inFlow Intraurethral Valve-Pump, a replaceable urinary prosthesis for use in female adults who cannot contract the muscles necessary to push urine out of the bladder (impaired detrusor contractility). A physician sizes the patient for an inFlow device and performs the initial insertion. After training, device insertion and removal can be performed by the patient or a caregiver. Each inserted component must be replaced at least once every 29 days. The inFlow Intraurethral Valve-Pump is manufactured by Vesiflo, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418835.htm


    The FDA has approved Obizur (antihemophilic factor [recombinant], porcine sequence) for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII deficiency). Obizur is manufactured by Baxter Healthcare Corporation.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm420263.htm


    The FDA has approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis. Ofev is a kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. Ofev is distributed by Boehringer Ingelheim Pharmaceuticals, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm


    Arbor Pharmaceuticals announced that the FDA has approved its New Drug Application for Sotylize (sotalol hydrochloride) oral solution. Sotylize is indicated for the treatment of documented life-threatening ventricular arrhythmias and the maintenance of normal sinus rhythm in patients with history of highly symptomatic atrial fibrillation/flutter. Arbor Pharmaceuticals will launch Sotylize in the first quarter of 2015.
    For more information, visit: arborpharma.com/10232014.php


    Pfizer Inc. announced that the FDA has granted accelerated approval of Trumenba (meningococcal group B vaccine) for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age. Approval of Trumenba is based on demonstration of immune response, as measured by serum bactericidal activity against four serogroup B strains representative of prevalent strains in the United States.
    For more information, visit: www.pfizer.com/news/press-release/press-release-detail/pfizer_receives_fda_accelerated_approval_for_trumenba_meningococcal_group_b_vaccine_for_the_prevention_of_invasive_meningococcal_b_disease_in_adolescents_and_young_adults

    Xigduo XR

    AstraZeneca announced that the FDA has approved once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. Xigduo XR combines two anti-hyperglycemic agents with complementary mechanisms of action, dapagliflozin (trade name in the United States, Farxiga), an inhibitor of sodium-glucose cotransporter 2 (SGLT2), and metformin hydrochloride extended-release, a biguanide, in a once-daily oral tablet. SGLT2 inhibitors are a relatively new class of medicines that remove glucose from the body via the kidneys.
    For more information, visit: www.astrazeneca.com/Media/Press-releases/Article/20141030-us-fda-approve-oncedaily-xigduo-xr

    FDA New Indications


    The FDA has approved Cyramza (ramucirumab) [Eli Lilly and Company] for use in combination with paclitaxel for the treatment of patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. Ramucirumab was approved in April 2014 as a single agent for the treatment of patients with advanced gastric or GEJ adenocarcinoma refractory to or progressive following first-line therapy with platinum or fluoropyrimidine chemotherapy.
    For more information visit: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm421930.htm


    Protein Sciences Corporation announced that the FDA has approved Flublok influenza vaccine for all adults aged 18 years and older, granting approval for use in people 50 and older. The expanded age indication means Flublok is now available for everyone over 50 who have been waiting patiently to receive his or her vaccine.
    For more information, visit: www.proteinsciences.com/PDF/pscp1.pdf


    Navidea Biopharmaceuticals, Inc. announced that the FDA has approved the Supplemental New Drug Application for the expanded use of Lymphoseek (technetium Tc 99m tilmanocept) injection for lymphatic mapping in solid tumors and adding Sentinel Lymph Node detection for breast cancer and melanoma to the approved indications. Lymphoseek is now indicated for: lymphatic mapping using a handheld gamma counter to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management, and guiding Sentinel Lymph Node Biopsy using a handheld gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity, breast cancer, or melanoma.
    For more information, visit: ir.navidea.com/phoenix.zhtml?c=68527&p=irol-newsArticle&ID=1977807


    The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, announced that the FDA has approved Velcade (bortezomib) for injection for use in previously untreated patients with mantle cell lymphoma (MCL). This approval extends the utility of Velcade beyond relapsed or refractory MCL, for which it has been approved since 2006.
    For more information, visit: www.takeda.com/news/2014/20141010_6789.html


    Auxilium Pharmaceuticals, Inc. announced that the FDA has approved a supplemental Biologics Application for Xiaflex (collagenase clostridium histolyticum or CCH) for the treatment of up to two Dupuytren's contracture joints in the same hand during a single treatment visit. Xiaflex consists of a combination of two subtypes of collagenase, derived from Clostridium histolyticum. Together, the collagenase subtypes are thought to work synergistically to break the bonds of the triple helix collagen structure.
    For more information, visit: ir.auxilium.com/phoenix.zhtml?c=142125&p=irol-newsArticle&ID=1979556

    FDA Labeling Changes


    The FDA has approved new labeling for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, an opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Embeda is the third ER opioid analgesic to be approved with labeling describing the product’s abuse-deterrent properties consistent with the FDA’s 2013 draft guidance, Abuse-Deterrent Opioids – Evaluation and Labeling. The new labeling includes a claim indicating that Embeda has properties that are expected to reduce oral abuse when the product is crushed.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm419288.htm

    FDA New Formulations

    Octagam 10%

    Octapharma USA announced the FDA has approved Octagam 10% (immune globulin intravenous (human) 10% 100mg/mL liquid preparation) for the treatment of chronic immune thrombocytopenic purpura, a platelet disorder that can result in easy or excessive bruising and bleeding. Octapharma USA has been marketing Octagam 5% (immune globulin intravenous (human) 5% 50mg/mL liquid preparation) to treat primary humoral immunodeficiency since 2004. As of July 17, 2014, Octagam 10% was expected to be available in the United States in September 2014.
    For more information, visit: www.octapharma.com/en/about/newsroom/press-releases/news-single-view.html?tx_ttnews%5Btt_news%5D=527&cHash=e006613e4e3cb269a050bbf0d6969a48


    Salix Pharmaceuticals, Ltd. announced that the FDA has granted final approval for Uceris (budesonide) rectal foam for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40cm from the anal verge. The foam is a rectally administered corticosteroid that overcomes treatment limitations associated with currently approved therapies that are often ineffective due to insufficient distribution of active drug to the distal colon.
    For more information, visit: news.salix.com/press-release/fda-approves-uceris-budesonide-2mg-rectal-foam-induction-remission-mild-moderate

    FDA Recalls

    10 Percent Neutral Buffered Formalin

    Richard-Allan Scientific discovered defective products returned from several customers were found to have from 0 percent to 3 percent Formalin content instead of the required 10 percent. A too-low or too-high concentration of Formalin will not properly preserve or can damage tissues. This recall was initiated on September 17, 2014 and includes 10 percent Neutral Buffered Formalin manufactured on July 18, 2014, and distributed between July 18 and September 17, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm421417.htm

    Assured Brand Naproxen Sodium Tablets

    Contract Packaging Resources, a drug repackaging company, is voluntarily recalling 11,640 boxes of Assured brand Naproxen Sodium tablets because some cartons actually contain bottles of Ibuprofen, a different pain reliever. The affected products are: boxes of Assured brand Naproxen Sodium Tablets 220mg, 15 count (Lot #FH4102A) [SKU #122368/UPC #639277223685] containing bottles of Ibuprofen softgels in 200mg strength. The recalled Assured brand drug products were distributed nationwide to Dollar Tree and sold via the Dollar Tree retail stores and internet site.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419769.htm

    CareFusion EnVe and ReVel Ventilators

    FDA notified health professionals and their medical care organizations of a Class I Recall of these products. There is a potential for damage to their power cord adaptors, which can cause loss of power and complete shut off. A short circuit in the power supply may prevent the ventilator battery from recharging, and the ventilator could lose power unexpectedly. The CareFusion EnVe and ReVel ventilators are used on patients who require respiratory support or mechanical ventilation and who weigh a minimum of 11 pounds (5kg). The recalled products were manufactured from May 2009 to August 2014 and distributed from December 10, 2010, to August 6, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418344.htm

    ICU Medical ConMed Stat2 Flow Controller

    FDA notified health professionals and their medical care organizations of a Class 1 recall of the Stat2 Flow Controller because it was assembled with the wrong internal component. The Flow Controller may deliver fluid at a much higher flow rate than what is set. IV administration sets are used to deliver or remove fluids from the body, with the amount of fluid delivered controlled by a flow controller. The affected item numbers: 011-C9801, 011-C9802, AH7007, B9897, Z2648 and affected lot numbers: 2768416, 2768417, 2758229, 2785379, 2801951, 34-128-HE, 34-540-Y1, 35-151-SJ, 35-805-JW, 36-137-SL, 36-469-SL. The recalled product was manufactured from October 2013 to January 2014 and distributed from October 2013 to January 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418345.htm

    Intravia Containers

    Baxter International Inc. announced it is voluntarily recalling two lots of Intravia containers in the United States and Canada due to complaints received for particulate matter found inside the fluid path. Intravia containers are empty plastic containers with PVC ports and a sterile fluid path. The recalled lots are Intravia Container, 150mL Capacity, Lot Number UR13D15112, Product Code 2B8011, distributed to customers between April 26, 2013, and June 20, 2013; and Intravia Container, Empty 500mL Capacity, Lot Number UR13K14095, Product Code 2B8013, distributed to customers between November 27, 2013, and March 10, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm420415.htm

    Lidocaine HCl for Injection, USP, 10mg per mL, 30mL Single-Dose, Preservative-Free

    Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10mg per mL, 30mL single-dose, preservative-free to the user level due to a confirmed customer report of particulate in a single unit. Hospira has identified the particulate as a human hair, embedded in and attached to a pinched area of the stopper. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in local inflammation, phlebitis, and/or low-level allergic response to the particulate or microembolic effects. This lot (NDC 0409-4279-02; Lot 40-316-DK, Expiry 1APRIL2016) was distributed nationwide from May 2014 through June 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419322.htm

    LifeCare Flexible Intravenous Solutions

    Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage. The issue was identified during re-inspection of a manufactured product lot in which a single puncture mark was identified going through the overwrap and primary container. The puncture in the primary container may result in leakage that is difficult to detect. Leakage may result in an open system, which has the potential for contamination, compromised sterility, drug waste, spillage, inadequate or inconsistent solution/medication dosing, and/or delay in therapy, all of which may require medical intervention. Hazardous topical exposure may occur if a hazardous drug is added to the flexible container. To date, there have been no reports of adverse events associated with this issue for the impacted lots. The affected lots were originally distributed by Hospira to direct accounts from September 2013 through October 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418887.htm

    Oregon Compounding Centers, Inc. Unexpired Sterile Products

    Oregon Compounding Centers, Inc., also called Creative Compounds, is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance. The company has not received any reports of product contamination or adverse events to date, but is issuing this voluntary recall following a recent inspection that identified an issue with sterility assurance. All recalled products have a label that includes the Creative Compounds name as well as a lot number. The recalled products were made from July 1, 2014, through September 22, 2014, and distributed to healthcare facilities, physicians, and patients in two states, Oregon and Washington. The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418359.htm

    Saba Shark Cartilage Complex

    AMS Health Sciences, LLC is notifying the public that it is recalling 2014 bottles of Saba Shark Cartilage Complex due to possible contamination of Salmonella. Product from this lot was sold to consumers through the Internet during the period of February through August 2014. Product from the affected lot can be identified by the Lot Number 416349 and an expiration date of 08/16.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm419445.htm

    FDA Alerts

    Expiration Date Extensions of Certain Auto-Injectors

    FDA is alerting healthcare professionals and emergency responders that specific lots of AtroPen (atropine), CANA (diazepam), morphine sulfate, and pralidoxime chloride auto-injectors manufactured by Meridian Medical Technologies can be used for up to one additional year beyond the manufacturer’s labeled expiration date. This notice is in follow up to the FDA’s November 22, 2013, statement, and will help mitigate potential shortages of these medically necessary drugs.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm376367.htm

    Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes

    Covidien announced that it has notified customers of a voluntary Field Safety Alert for certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillators. Covidien has received two reports where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm418644.htm