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  • FDA Drug Updates

    FDA New Approvals


    Aqua Pharmaceuticals, an Almirall company, has announced the FDA approval for Acticlate (doxycycline hyclate USP) Tablets, 150mg and 75mg. Acticlate is a tetracycline-class antibacterial indicated for the treatment of a number of infections, including adjunctive therapy in severe acne.
    For more information, visit: www.aquapharm.com/pdf/ActiclateApprovalPressRelease.pdf

    Flonase Allergy Relief

    GlaxoSmithKline announced that the FDA has approved Flonase Allergy Relief (fluticasone propionate 50mcg spray) as an over-the-counter (OTC) treatment for temporary relief of the symptoms of hay fever or upper respiratory allergies. Flonase Allergy Relief is the first and only OTC nasal spray indicated for relief of all nasal and eye-related allergy symptoms, including runny nose, sneezing, itchy nose, nasal congestion, and itchy and watery eyes. Flonase Allergy Relief will be available at full prescription strength to provide 24-hour non-drowsy allergy relief. Flonase Allergy Relief will be available OTC in early 2015.
    For more information, visit: www.gsk.com/media/press-releases/2014/fda-approves-flonase-allergy-relief-for-sale-over-the-counter-in.html


    The FDA has approved Jardiance (empagliflozin) tablets as an addition to diet and exercise to improve glycemic control in adults with type 2 diabetes. Jardiance is a sodium glucose co-transporter 2 inhibitor. Jardiance has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, including metformin, sulfonylureas, pioglitazone, and insulin. Jardiance should not be used: to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); and in those with severe renal impairment, end stage renal disease, or in patients on dialysis. Jardiance is distributed by Boehringer Ingelheim Pharmaceuticals, Inc.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm407637.htm


    Anacor Pharmaceuticals, Inc. announced that the FDA has approved the New Drug Application for Kerydin (tavaborole) topical solution, 5%. Kerydin (tavaborole) topical solution, 5%, is the first oxaborole antifungal agent developed for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Kerydin is a clear, colorless, alcohol-based solution applied with a dropper to the infected toenail once daily for 48 weeks.
    For more information, visit: http://investor.anacor.com/releasedetail.cfm?ReleaseID=858211

    NovoSeven RT

    Novo Nordisk announced that the FDA has approved NovoSeven RT (Coagulation Factor VIIa [Recombinant]) as the first recombinant treatment for bleeding episodes and perioperative management in patients with Glanzmann's thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.
    For more information, visit: http://press.novonordisk-us.com/2014-07-07-FDA-Approves-NovoSeven-RT-for-the-Treatment-of-Glanzmanns-Thrombasthenia-GT-With-Refractoriness


    The FDA has approved Rasuvo (methotrexate), a subcutaneous injectable methotrexate delivered in an auto-injector for rheumatoid arthritis, polyarticular-course juvenile idiopathic arthritis, and psoriasis. Rasuvo will be available in 10 dosage strengths, ranging from 7.5mg to 30mg in 2.5-mg increments.
    For more information visit: www.rasuvo.com


    Salix Pharmaceuticals, Ltd. and Pharming Group announced that the FDA has approved Ruconest (C1 Esterase Inhibitor [Recombinant]) 50 IU/kg for the treatment of acute angioedema attacks in adult and adolescent patients with hereditary angioedema. Ruconest received orphan-drug designation for acute attacks by the FDA because it is intended for treatment of a rare disease or condition. Ruconest is manufactured by Pharming Group NV, and will be distributed in the United States by Santarus Inc., a wholly owned subsidiary of Salix Pharmaceuticals Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm405526.htm


    Eagle Pharmaceuticals, Inc. announced that the FDA has approved Ryanodex (dantrolene sodium) for injectable suspension indicated for the treatment of malignant hyperthermia (MH), along with the appropriate supportive measures. Ryanodex is the first significant enhancement to MH treatment options in more than three decades, reformulated to improve performance in managing MH. Ryanodex will be available to order through national and regional drug wholesalers in August with product shipping shortly after.
    For more information, visit: http://investor.eagleus.com/press-release/fda-approves-eagle-pharmaceuticals-ryanodex-treatment-malignant-hyperthermia

    Striverdi Respimat

    The FDA has approved Striverdi Respimat (olodaterol) inhalation spray to treat patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema, who are experiencing airflow obstruction. Striverdi Respimat can be used once daily over a long period of time. Striverdi Respimat is a long-acting beta-adrenergic agonist that helps the muscles around the airways in the lungs stay relaxed to prevent symptoms. Striverdi Respimat should not be used in patients with acutely deteriorating COPD and may cause serious side effects, including narrowing and obstruction of the respiratory airway (paradoxical bronchospasm) and cardiovascular effects. Striverdi Respimat is distributed by Boehringer Ingelheim Pharmaceuticals, Inc.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm407465.htm

    Targiniq ER

    The FDA has approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), an extended-release/long-acting 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. Targiniq ER has properties that are expected to deter, but not totally prevent, abuse of the drug by snorting and injection. When crushed and snorted, or crushed, dissolved, and injected, the naloxone in Targiniq ER blocks the euphoric effects of oxycodone, making it less liked by abusers than oxycodone alone. Targiniq ER is manufactured by Purdue Pharma L.P.
    For more information, visit: www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm406290.htm


    The FDA has approved Zydelig (idelalisib) to treat patients with three types of blood cancers. Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has relapsed. Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom Rituxan alone would be considered appropriate therapy due to other existing medical conditions (co-morbidities). Zydelig is the fifth new drug with breakthrough therapy designation to be approved by the FDA and the third drug with this designation approved to treat CLL. The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma, another type of non-Hodgkin lymphoma. Zydelig is intended to be used in patients who have received at least two prior systemic therapies. Zydelig is marketed by Gilead Sciences.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm406387.htm

    FDA New Indications


    Purdue Pharma L.P. announced that the FDA has approved a new 7.5mcg/hr dosage strength of Butrans (buprenorphine) Transdermal System CIII. Five strengths of Butrans will now be available: 5mcg/hr, 7.5mcg/hr, 10mcg/hr, 15mcg/hr, and 20mcg/hr. The Butrans Transdermal System is also approved to allow the use of two patches to facilitate dose adjustments during titration. The total dose from both patches should not exceed 20mcg/hr. Purdue expects to launch Butrans 7.5mcg/hr commercially in the United States in October 2014.
    For more information, visit: www.purduepharma.com/news-media/2014/07/purdue-pharma-l-p-receives-fda-approval-for-7-5-mcghour-dosage-strength-of-butrans-buprenorphine-transdermal-system-ciii/


    Regeneron Pharmaceuticals, Inc. announced that the FDA has approved Eylea (aflibercept) Injection for the treatment of diabetic macular edema. Eylea is a vascular endothelial growth factor inhibitor formulated as an injection for the eye. Eylea is available as a single, 2-mg strength intravitreal injection for all approved indications. Bayer HealthCare and Regeneron are collaborating on the global development of Eylea.
    For more information, visit: http://files.shareholder.com/downloads/REGN/3376854422x0x772028/698a12f7-a8dc-4f89-b9e2-f8134ae6f3de/REGN_News_2014_7_29_General_Releases.pdf


    The FDA has expanded the approved use of Imbruvica (ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) who carry a deletion in chromosome 17 (17p deletion), which is associated with poor responses to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use. Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. Imbruvica is co-marketed by Pharmacyclics and Janssen Biotech.
    For more information, visit: www.fda.gov/newsevents/newsroom/pressannouncements/ucm406916.htm


    The FDA has announced the approval of Lumizyme (alglucosidase alfa) for treatment of patients with infantile-onset Pompe disease, including patients who are less than 8 years of age. In addition, the Risk Evaluation and Mitigation Strategy (REMS) known as the Lumizyme Alglucosidase Alfa Control and Education (ACE) Program is being eliminated. Distribution of Lumizyme will no longer be restricted. Healthcare professionals, healthcare facilities, and patients will no longer be required to enroll in the Lumizyme REMS program (Lumizyme ACE Program) to be able to prescribe, dispense, or receive Lumizyme.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm407563.htm

    FDA Recalls

    Intravenous Solutions

    Baxter International Inc. announced today that it is voluntarily recalling four lots of intravenous solutions to the hospital/user level. These products have been found to contain particulate matter identified as cellulosic fibers and/or plastics. Baxter received four complaints over a period of six months from customers whose visual inspection identified the appearance of visible particulate matter prior to administration to a patient. If infused, adverse health consequences of particulate matter could vary depending on the amount of particulate matter injected into the patient, the size of the particles, the patient’s underlying medical condition, and the presence of a right-to-left cardiac shunt. The presence of particulate foreign matter may elicit inflammatory and allergic responses, both chronic and acute, and may be life threatening. There have been no reported adverse events associated with this issue to date, and an investigation is underway to determine root cause. Sodium Chloride Injection, USP is an intravenously administered injectable indicated as a source of water and electrolytes, for use as a priming solution in hemodialysis procedures, and may be used as a diluent for reconstitution of a powdered drug product. Potassium Chloride Injection is an intravenously administered injectable indicated as a potassium replacement to support nerve conduction, muscle contraction, and prevention of cardiac arrhythmias. The lots being recalled were distributed worldwide to customers and distributors between February 2013 and June 2014.
    For more information visit: www.fda.gov/Safety/Recalls/ucm405469.htm

    Ibuprofen Tablets and Oxcarbazepine Tablets

    American Health Packaging (AHP) has voluntarily recalled Lot #142588, Expiration Date, 01/2016 of Ibuprofen Tablets, USP, 600mg, in a hospital unit dose presentation that may contain individual blistered doses labeled as Oxcarbazepine Tablets, 300mg, lot #142544. In addition, AHP has voluntarily recalled Oxcarbazepine Tablets, 300mg, lot #142544, Expiration Date, 02/2016. This voluntary recall is the result of mislabeled inner unit dose blister packaging which could result in patients receiving ibuprofen and missing their scheduled dose of oxcarbazepine. These hospital unit dose products were distributed nationwide beginning June 20, 2014. No other products or lots were affected by this incident.
    For more information visit: www.fda.gov/Safety/Recalls/ucm405989.htm

    Lactated Ringers and 5% Dextrose Injection, USP, 1000mL, Flexible Container

    Hospira, Inc. announced it is initiating a voluntary nationwide user-level recall of one lot of Lactated Ringers and 5% Dextrose Injection, USP, 1000mL, Flexible Container, NDC 0409-7929-09, Lot 35-118-JT, Expiry 1NOV2015. This action is due to one confirmed customer report where particulate was identified within the solution of the primary container. The particulate was identified as a filamentous-like structured particulate indicative of mold. This lot was distributed nationwide from December 2013 through February 2014 and was distributed to hospitals, clinics, wholesalers, and distributors.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm404667.htm

    Lidocaine HCI Injection, USP, 2%, 20mg/mL, 5mL Single-Dose Vial, Preservative-Free

    Hospira, Inc. has announced it will initiate a voluntary recall of one lot of Lidocaine HCI Injection, USP, 2%, 20mg/mL, 5mL Single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level, due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide. To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to supplier’s glass defect. Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. This lot was distributed nationwide to distributors/wholesalers, hospitals, and clinics from June 2013 through July 2013.
    For more information visit: www.fda.gov/Safety/Recalls/ucm407169.htm

    Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC)

    GE Healthcare, LLC is recalling Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC). The affected CO2 detectors may fail or provide incorrect CO2 values for mechanically and spontaneous ventilated patients. Physicians may make decisions based on incorrect values, which could lead to permanent, irreversible impairment, or life-threatening changes in patients. Patients may experience an inadequate exchange of gases (hypoventilation), causing an increased concentration of CO2 (hypercapnia). Death may also occur as a result of low CO2 values.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm406730.htm

    Unique Pharmaceuticals Sterile Products

    Unique Pharmaceuticals, Ltd. ("Unique" or "the Company") announced a voluntary nationwide recall of all sterile drug preparations compounded by the outsourcing facility that have not reached the expiration date listed on the products. Unique is initiating the recall due to the FDA's concerns associated with Unique's compounding facilities and compounding processes that the FDA contends present a lack of sterility assurance and were observed during recent FDA inspections. The preparations covered by this recall were distributed nationwide. Until further notice, healthcare providers should stop using all lots of sterile products prepared by Unique that are within their expiry period and return them to the Company. Unique will be notifying customers by phone, fax, mail, or personal visits to return the products to the Company.
    For more information visit: www.fda.gov/Safety/Recalls/ucm405938.htm

    Langston Dual Lumen Catheters

    Vascular Solutions, Inc. initiated a voluntary nationwide recall of Langston dual lumen catheters used in catheterization procedures. The Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular, and intraventricular pressure gradients. Specific lots of the products have been recalled because of the potential for the inner catheter to separate from the hub during use and travel into the patient’s circulation. This may require an intervention or surgery to retrieve the separated piece. In addition, the operator may be at increased risk of contact with contrast or bodily fluid, which could potentially result in infection or injury to the operator. To date, there have been two reports of the inner catheter entering the patient’s ventricle, requiring retrieval. No injuries have been reported.
    For more information visit: www.fda.gov/Safety/Recalls/ucm404253.htm

    FDA Alerts

    NuVision Pharmacy

    FDA is alerting healthcare professionals and consumers not to use drugs marketed as sterile produced by Downing Labs LLC, also known as NuVision Pharmacy, in Dallas, as they may be contaminated. Administration of a non-sterile drug product intended to be sterile may result in serious and potentially life-threatening infections or death. Healthcare professionals should immediately check their medical supplies, quarantine any sterile drug products from NuVision, and not administer them to patients. Patients who have received any drug product produced by NuVision and have concerns should contact their healthcare professional.
    For more information visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm405941.htm