• PDR Search

    Required field
  • Advertisement
  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Alprolix, Coagulation Factor IX (Recombinant), Fc Fusion Protein, for use in adults and children who have Hemophilia B. Alprolix is approved to help control and prevent bleeding episodes, manage bleeding during surgical procedures, and prevent or reduce the frequency of bleeding episodes (prophylaxis). Alprolix consists of the Factor IX molecule linked to a protein fragment, Fc, which is found in antibodies. This makes the product last longer in circulation. Alprolix received orphan-drug designation for this use by the FDA because it is intended for treatment of a rare disease or condition. Alprolix is manufactured by Biogen Idec, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391037.htm


    The FDA has allowed marketing of the first device as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation device specifically authorized for use prior to the onset of pain. Cefaly is a small, portable, battery-powered,prescription device that resembles a plastic headband worn across the forehead and atop the ears. Cefaly is indicated for patients 18 years of age and older and should only be used once per day for 20 minutes. The FDA reviewed the data for Cefaly through the de novo premarket review pathway, a regulatory pathwayfor generally low- to moderate-risk medical devices that are not substantially equivalent to an already legally marketed device. Cefaly is manufactured by STX-Med.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm388765.htm


    The FDA has approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can becarried in a pocket or stored in a medicine cabinet. It is intended for the emergency treatment of known or suspected opioid overdose, characterized by decreased breathing or heart rates, or loss of consciousness. Evzio is injected intramuscularly or subcutaneously. Once turned on, the device provides verbal instructionto the user describing how to deliver the medication, similar to automated defibrillators. Evzio is manufactured for kaléo, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391465.htm


    Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy.” Hemangeol isan oral solution specially developed for safe and effective use in children. Hemangeol will be available June 2014.
    For more information, visit: www.pierre-fabre.com/sites/default/files/files/document/file/pr_fda_hemangeol_pfd_17032014_en.pdf


    The FDA has approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Impavido is an oral medicine approved to treat the three main types of leishmaniasis: visceral leishmaniasis, cutaneous leishmaniasis, and mucosal leishmaniasis. It is intended for patients 12 yearsof age and older. Impavido is the first FDA-approved drug to treat cutaneous or mucosal leishmaniasis. The FDA granted Impavido fast track designation, priority review, and orphan product designation. The labeling for Impavido includes a boxed warning to alert patients and healthcare professionals thatthe drug can cause fetal harm and therefore should not be given to pregnant women.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm389671.htm


    Piramal Imaging has announced that the FDA has approved Neuraceq. Neuraceq is indicated for positron emission tomography imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.
    For more information, visit: www.piramal.com/imaging/pdf/FDA-Approval-Press-Release.pdf

    Nexium 24HR

    The FDA has approved over-the-counter Nexium 24HR (esomeprazole 20mg). In 2012, Pfizer acquired exclusive global rights from AstraZeneca to market non-prescription Nexium.
    For more information, visit: www.pfizer.com/news/press-release/press-release-detail/pfizer_statement_on_u_s_fda_approval_of_over_the_counter_nexium_24hr

    Nucleus Hybrid L24 Cochlear Implant System

    The FDA has approved the first implantable device for people 18 years of age and older with severe or profound sensorineural hearing loss of high-frequency sounds in both ears, but who can still hear low-frequency sounds with or without a hearing aid. The Nucleus Hybrid L24 Cochlear Implant System may help those with this specific kind of hearing loss who do not benefit from conventional hearing aids. The Nucleus Hybrid L24 Cochlear Implant System combines the functions of a cochlear implant and a hearing aid. This electronic device consists of an external microphone and speech processor that picks up sounds from the environment and converts them into electrical impulses. The impulses are transmitted to the cochlea through a small bundle of implanted electrodes, creating a sense of sound that the user learns to associate with the mid- and high-frequency sounds they remember. The hearing aid portion of the device is inserted into the outer ear canal like a conventional hearing aid, and can amplify sounds in the low-frequency range. The Nucleus Hybrid L24 Cochlear Implant System is manufactured by Cochlear Ltd.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm389860.htm


    Greer Laboratories, Inc. has announced that the FDA has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet. Oralair is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies for any of the five grass species contained in the product. Oralair is approved for use in persons 10 through 65 years of age. Oralair is a tablet that dissolves under the tongue. The first dose is taken in the doctor’s office under medical supervision, and subsequent doses are administered once a day by the patient or the patient’s caregiver. Oralair should be started four months before the expected onset of each grass pollen season and treatment continued throughout the season. Oralair may reduce grass allergy symptoms for patients within the first allergy season that it is taken.
    For more information, visit: www.greerlabs.com/files/ORALAIR-FDA-Approval-Release.pdf


    The FDA has approved Otezla (apremilast) to treat adults with active psoriatic arthritis. The FDA is requiring a pregnancy exposure registry as a post-marketing requirement to assess the risks to pregnant women related to Otezla exposure. Otezla is manufactured for Celgene Corporation.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm390091.htm

    Qudexy XR

    Upsher-Smith Laboratories, Inc. has announced that it has received approval from the FDA for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.Qudexy XR is indicated as initial monotherapy in patients 10 years of age and older with partial-onset seizures (POS) or primary generalized tonic-clonic seizures. It is also approved as adjunctive therapy in patients 2 years of age and older with POS, primary generalized tonic-clonic seizures, and seizuresassociated with Lennox-Gastaut syndrome. Qudexy XR is available in 25mg, 50mg, 100mg, 150mg, and 200mg extended-release capsules. Qudexy XR will be available to patients in the second quarter of 2014.
    For more information, visit: www.upsher-smith.com/wp-content/uploads/108885.01-QXR-PR-FDA-Approval-FINAL.pdf

    Xartemis XR

    Mallinckrodt plc announced that the FDA has approved Xartemis XR (oxycodone hydrochloride and acetaminophen) extended-release tablets (CII), previously known as MNK-795, for the management of acute pain severe enough to require opioid treatment and in patients for whom alternative treatment options (eg, non-opioid analgesics) are ineffective, not tolerated, or would otherwise be inadequate. Xartemis XR is the first and only extended-release oral combination of oxycodone and acetaminophen.
    For more information, visit: phx.corporate-ir.net/phoenix.zhtml?c=251847&p=irol-newsArticle

    FDA First-Time Generic Approvals

    Lovaza Generic

    Teva Pharmaceutical Industries Ltd. announced the approval of the generic equivalent to Lovaza (omega-3-acid ethyl esters capsules, USP), in the US. Teva plans to commence shipping immediately.
    For more information visit: www.tevapharm.com/Media/News/Pages/2014/1916694.aspx

    FDA New Indications


    Bristol-Myers Squibb Company and Pfizer Inc. announced that the FDA has approved a Supplemental New Drug Application for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis, which may lead to pulmonary embolism, in patients who have undergone hip or knee replacement surgery.
    For more information, visit: news.bms.com/press-release/us-fda-approves-eliquis-apixaban-reduce-risk-blood-clots-following-hip-or-knee-replace


    Boehringer Ingelheim Pharmaceuticals Inc. announced that the FDA has approved Pradaxa (dabigatran etexilate mesylate) for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for five to 10 days, and for reduction of the risk of recurrent DVT and PE in patients who have been previously treated.
    For more information visit: www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/08_april_2014_dabigatranetexilate.html


    The FDA has approved Topamax (topiramate) for prophylaxis of migraine headaches in adolescents 12 to 17 years of age. This is the first FDA approval of a drug for migraine prevention in this age group. The medication is taken on a daily basis to reduce the frequency of migraine headaches. Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004. Topamax must be dispensed with a Medication Guide that describes important safety information about the drug. Topamax is manufactured by Janssen Pharmaceuticals, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm391026.htm


    Novartis has announced that the FDA has approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU). In the US, Xolair is indicated for CIU in adults and adolescents 12 years of age or older who remain symptomatic despite H1-antihistamine treatment. Xolair is being jointly developed by Novartis and Genentech, Inc.
    For more information, visit: www.novartis.com/newsroom/media-releases/en/2014/1770973.shtml

    FDA New Formulations

    Noxafil Injection

    Merck has announced that the FDA has approved Noxafil (posaconazole) injection (18mg/mL), a new formulation of Noxafil for intravenous use. Merck’s antifungal agent is also marketed as Noxafil (100mg) delayed-release tablets and Noxafil (40mg/mL) oral suspension. Noxafil injection, delayed-release tablets, and oral suspension are indicated for prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant recipients with graft-versus-host disease or those with hematologic malignancies with prolonged neutropenia from chemotherapy. Noxafil injection is indicated in patients 18 years of age and older. Noxafil delayed-release tablets and oral suspension are indicated in patients 13 years of age and older. Noxafil injection is expected to be available at wholesalers in mid-April.
    For more information, visit: www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-noxafil-posaconazole-injection-18-mgml-i

    FDA Recalls


    GlaxoSmithKline (GSK) Consumer Healthcare is voluntarily recalling all alli weight loss products from US and Puerto Rico retailers, as the company believes that some packages of the product were tampered with and may contain product that is not authentic alli. GSK is conducting an investigation and is working with the knowledge of the FDA on this retailer level recall. GSK received inquiries from consumers in seven states about bottles of alli that contained tablets and capsules that were not alli. A range of tablets and capsules of various shapes and colors were reported to be found inside bottles. Additionally, some bottles inside the outer carton were missing labels and had tamper-evident seals that were not authentic. These tampered products were purchased in retail stores.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm391004.htm

    FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter

    Abbott is voluntarily conducting a recall for the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter. When used with the Abbott FreeStyle test strips, the FreeStyle Blood Glucose Meter and the FreeStyle Flash Blood Glucose Meter may produce mistakenly low blood glucose results. These two meters have not been in production since 2010. Other Abbott Diabetes Care meters are not affected by the recall.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm389357.htm

    Hemoset Dual Channel Plum Sets

    Hospira, Inc. has announced a nationwide recall of two lots of Hemoset Dual Channel Plum Sets (list number 11241-03, lot numbers 28005-5H and 34100-5H). Hospira identified that an incorrect set component was supplied and used during the manufacturing process of the impacted product lots. There have been no related customer reports received to date and Hospira is conducting this recall as a precautionary measure. The blood sets impacted by the recall were distributed to US healthcare and veterinary facilities from May 2013 through December 2013.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm389533.htm

    1% Lidocaine HCl Injection

    Hospira, Inc. is recalling one lot (# 25-090-DK) of 1% Lidocaine HCl Injection, which is contained in the Merit Medical Systems Custom Procedural Trays/Kits. These trays/kits were recalled due to one confirmed customer report of visible particulate, identified in the primary product container, in the form of dark red/black particles. The particulate was identified as oxidized stainless steel. The affected products were manufactured from April 29, 2013 through August 20, 2013 and distributed from April 30, 2013 through September 20, 2013.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389217.htm

    McKesson Technologies Anesthesia Care

    The FDA has notified health professionals of a Class I recall of McKesson Technologies Anesthesia Care, a computer-based system that collects, processes, and records data both through manual entry and from monitors that are attached to patients, such as in an operating room environment. There was anoccurrence where the patient case data did not match the patient data when the case was recalled in the Anesthesia Care Record in that it included data from another case. Use of this affected product may cause serious adverse health consequences, including death.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm389356.htm

    Optional PS500 Power Supply for Evita V500 and Babylog VN500 Ventilators

    Dräger has initiated a nationwide recall of the optional PS500 Power Supply Unit used with the Evita V500 and Babylog VN500 ventilators. This voluntary action was a result of an internal investigation by Dräger into complaints that found that the batteries installed in the PS500 depleted muchearlier than expected, although the battery indicator showed a significantly charged battery. As a result, the device may not indicate a low battery charge. The first indication of diminished battery capacity may occur when the battery is totally depleted. This recall only affects Evita V500 and Babylog VN500ventilators equipped with the optional PS500 power supply unit. Affected devices were distributed nationally between June 2011 and January 2014. Initial investigation revealed that the battery capacity was reduced due to the occurrence of sulfation within the battery. Frequent short-time use of PS500battery power can increase sulfation, further reducing the battery capacity. When sufficient sulfation occurs, the connection to main power cannot guarantee fully charged batteries and the charge indicator may not reflect the currently available battery capacity. In some cases, neither the “Battery Low” nor the“Battery Depleted” alarm was triggered when the remaining battery capacity fell below 10%. However, when the battery depleted totally, the power fail alarm was generated. To date, there have been no patient injuries reported due to this issue.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm391472.htm


    Shire Pharmaceuticals has announced the initiation of a voluntary recall in the US of one batch, packaged into three lots, of Vpriv due to the presence of visible particulate matter, identified as stainless steel and barium sulfate. The particulate matter was found in a small number of vials inthe three packaged lots of Vpriv. A Shire investigation identified the particulate matter root cause as the third party supplier fill finish process. There have been no reported adverse events or customer complaints associated with the use of these lots.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm389300.htm

    FDA Alerts


    Forest Laboratories, Inc. has announced that it plans to discontinue the sale of Namenda (memantine hydrochloride) 5mg and 10mg tablets, effective August 15, 2014. Forest has notified the FDA of this decision. The oral solution of Namenda and once-daily Namenda XR (memantine hydrochloride) extended-releasecapsules will continue to be available. Both Namenda and Namenda XR are indicated for the treatment of moderate to severe Alzheimer’s disease.
    For more information, visit: news.frx.com/press-release/business-development-news/forest-laboratories-discontinue-namenda-tablets-focus-once-d


    The FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in adults, not in children; however, healthcare professionals must consider whether the benefitsof treatment with the drug are likely to outweigh its potential risks for each patient. The FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation ofincreasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with PAH. The FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, whenother treatment options are limited and Revatio can be used with close monitoring.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm391152.htm

    Standard Offset Cup Impactors

    Greatbatch, Inc. has initiated a voluntary field corrective action for all Standard Offset Cup Impactors after an internal review determined that the sterilization recommendation in the Instructions for Use for the product did not meet requirements for sterility assurance, whichhas the potential to result in surgical infection. No incidents have been reported during clinical use of the product, nor have there been any reported adverse events. Greatbatch has developed new sterilization recommendations that meet acceptable sterility assurance levels (AAMI ST79 standard) and providedthem to affected customers.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm388883.htm