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  • FDA Drug Updates

    FDA New Approvals


    Amgen announced that the FDA has granted approval of Blincyto (blinatumomab) for the treatment of patients with Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. This indication is approved under accelerated approval. Continued approval for this indication may be contingent upon verification of clinical benefit in subsequent trials.
    For more information, visit: www.amgen.com/media/media_pr_detail.jsp?releaseID=1994704

    HeartFlow FFR-CT

    The FDA has allowed marketing of the HeartFlow FFR-CT software, which permits healthcare professionals to non-invasively evaluate blood flow in the coronary arteries of patients showing signs and symptoms of coronary artery disease. The HeartFlow FFR-CT software is housed at HeartFlow, Inc.’s headquarters in Redwood City, California. A healthcare professional electronically sends the patient’s CT scan data to HeartFlow, Inc. where a case analyst creates 3D computer models of different sections of the patient’s heart and runs a blood flow simulator program on the models. After analyzing the data and the models, the case analyst electronically sends a report with the estimated FFR values (called FFR-CT values) displayed as color images of the patient’s heart.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424945.htm

    Hysingla ER

    Purdue Pharma L.P. announced that the FDA approved Hysingla ER (hydrocodone bitartrate) extended-release tablets CII, a once-daily, single-entity medication formulated using Purdue’s proprietary extended-release solid oral platform, Resistec. It is the first and only hydrocodone product to be recognized by the FDA as having abuse-deterrent properties that are expected to deter misuse and abuse via chewing, snorting, and injection. However, abuse of Hysingla ER by the intravenous, intranasal, and oral routes is still possible.
    For more information, visit: www.purduepharma.com/news-media/2014/11/purdue-pharma-l-p-receives-fda-approval-for-hysinglatm-er-hydrocodone-bitartrate-extended-release-tablets-cii-a-once-daily-opioid-analgesic-formulated-with-abuse-deterrent-properties/


    Genzyme, a Sanofi company, announced that the FDA has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). Because of its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
    For more information, visit: news.genzyme.com/press-release/genzymes-lemtrada-approved-fda


    Valeant Pharmaceuticals International, Inc. announced that it has received approval from the FDA for Onexton Gel (clindamycin phosphate and benzoyl peroxide), 1.2%/3.75%, for the once-daily treatment of comedonal (non-inflammatory) and inflammatory acne in patients 12 and older.
    For more information, visit: ir.valeant.com/investor-relations/news-releases/news-release-details/2014/Valeant-Pharmaceuticals-Announces-FDA-Approval-Of-ONEXTON-Gel-For-The-Treatment-Of-Acne-Vulgaris/default.aspx

    FDA New Indications


    Genentech, a member of the Roche Group, has announced that the FDA approved Avastin in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer. The new indication of Avastin is in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received no more than two prior chemotherapy regimens. With this approval, Avastin is approved in the United States to treat six distinct tumor types.
    For more information, visit: www.gene.com/media/press-releases/14578/2014-11-14/fda-approves-genentechs-avastin-bevacizu


    Incyte Corporation announced that the FDA has approved Jakafi (ruxolitinib) for the treatment of patients with polycythemia vera who have had an inadequate response to or are intolerant of hydroxyurea. Jakafi is also indicated for treatment of people with intermediate or high-risk myelofibrosis (MF), including primary MF, post-polycythemia vera MF, and post-essential thrombocythemia MF.
    For more information, visit: investor.incyte.com/phoenix.zhtml?c=69764&p=irol-newsArticle&ID=1995014

    Invega Sustenna

    Janssen Pharmaceuticals, Inc. announced that the FDA approved the supplemental New Drug Applications for the once-monthly atypical long-acting antipsychotic Invega Sustenna (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.
    For more information, visit: www.janssenpharmaceuticalsinc.com/assets/IS_SCA_sNDA_Approval_Press_Release.pdf


    Medivir AB announced that the FDA has approved Olysio (simeprevir) in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C infection in adult patients as part of a combination antiviral treatment regimen. The supplemental New Drug Application was filed in May by Medivir’s partner Janssen Research & Development LLC. Olysio was approved in November 2013 for the treatment of chronic hepatitis C infection as part of an antiviral treatment regimen in combination with pegylated interferon and ribavirin in genotype 1 infected adults with compensated liver disease, including cirrhosis.
    For more information, visit: www.medivir.se/v5/en/uptodate/pressrelease.cfm?releaseid=382F19A09DE25BB5&year=2014


    Sanofi announced that following a priority review, the FDA has approved Priftin (rifapentine) in combination with isoniazid for a new indication for the treatment of latent tuberculosis infection in patients two years of age and older at high risk of progression to tuberculosis disease. Priftin is an antimycobacterial that has been approved since 1998, in combination with one or more antituberculosis drugs, for the treatment of active pulmonary tuberculosis caused by Mycobacterium tuberculosis.
    For more information, visit: www.news.sanofi.us/index.php?s=33507&item=136875

    FDA Recalls

    ABC Dophilus Powder

    Solgar, Inc. is voluntarily recalling ABC Dophilus Powder. The recall was initiated, out of an abundance of caution, because the product was found to contain Rhizopus oryzae, which may cause mucormycosis. This rare infection may cause health problems to consumers, particularly premature infants/infants, children, and those with weakened immune systems. The affected lot numbers are: 074024-01R1, 074024-01, 074024-02 with an expiration date of 7/31/15.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm423219.htm

    Esprit V1000 and V200 Ventilators

    Respironics California Inc. has initiated a recall of Esprit V1000 and V200 Ventilators, Model V1000 and V200, installed with 3rd Generation Power Supplies, and 3rd Generation Power Supply Repair Part Kits. These devices were manufactured and distributed from December 21, 2012 to July 9, 2014. A part in the 3rd Generation Power Supply may prevent the ventilator from using AC power (electricity from a wall socket) or may fail and prevent the ventilator from switching back to AC power after using battery power. Additionally, if a battery is not present or is used up, the ventilators will not work. Failure of the power supply may cause the ventilator to shut off, which may result in too much carbon dioxide in a patient’s blood, not enough oxygen in the blood, or death.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm423919.htm

    Gabapentin Capsules, USP 300mg

    Aurobindo Pharma USA is voluntarily recalling one lot of Gabapentin Capsules, USP 300mg to the consumer level. The product lot has been found to contain some empty capsules. The affected Gabapentin lot is GESB14011-A, Expiration 12/2015 and is packaged in 100-count bottles, NDC 16714-662-01. The product can be identified by the imprint D on yellow cap and 03 on yellow body with black edible ink. Product was distributed through Northstar label to retail outlets nationwide.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm424470.htm

    Gel-E Donut and Squishon 2 Products

    Children’s Medical Ventures, a Philips Healthcare business, announced that the company has issued a recall of all Gel-E Donut gel pillow and Squishon 2 gel cushion products due to potential mold contamination of the products. The affected model numbers: 92025-A, 92025-B, 92025-C, 91033-2 were manufactured and distributed between July 2012 and August 2014. The model number is printed directly on the product.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm423199.htm

    GemStar Power Supply, 3VDC for GemStar Infusion Pumps

    Hospira received a total of 20 reported incidents including one report of smoke and found that the GemStar Infusion Pump was operating on battery power while connected to the 3VDC power supply. The power supply may not properly deliver electric power to the GemStar Infusion Pump. If the power supply fails, planned infusion therapy may be delayed if a backup power supply is not used. There were no reports of injuries or death. The firm noted that all 13,002 units distributed worldwide, with 5,687 of those units distributed in the United States, may fail.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm421951.htm

    Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL

    Baxter International Inc. voluntarily recalled one lot of Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL to the user level due to a complaint of mislabeling of the overpouch. Some containers of Product Code 2B0826, Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL, Lot Number P319160, Exp. 06/30/2015, NDC 0338-0709-48 were incorrectly labeled on the overpouch as Highly Concentrated Potassium Chloride Injection, 20 mEq per 100 mL.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424276.htm

    Mayhem Dietary Supplement

    Chaotic Labz is voluntarily conducting a nationwide recall of Mayhem dietary supplement capsules, Lot #CLM061114 with an expiration date of 06/2016, to the user/consumer level. Mayhem’s intended use is as a bodybuilding supplement. FDA laboratory analysis found that Mayhem Dietary Supplement contains undeclared dexamethasone, a prescription corticosteroid commonly used to treat inflammatory conditions, and cyproheptadine, a prescription antihistamine used for seasonal allergy treatment, making this an unapproved drug.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm423203.htm

    PadPro and R2 Multi-function Defibrillation Electrodes

    Conmed Corporation notified customers of a Voluntary Urgent Device Correction for certain PadPro and R2 Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user will not discover the incompatibility issue until the AED must be used. The affected multi-function electrodes were distributed globally to distributors and medical facilities from March 1, 2012 through October 29, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424952.htm

    Puritan Bennett, 980 Ventilator System

    FDA notified health professionals and their medical care organizations of the Class 1 recall of the Puritan Bennett 980 Ventilator Systems with software versions below 2.8, with distribution dates March 3, 2014 through August 22, 2014. The recalled products have a software problem that causes the ventilator to stop working after the air and oxygen gas supply lines are disconnected and then reconnected, which could lead to serious health problems or death.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm422362.htm

    Rapid Gram Negative Combo Panels, Class I Recall - May Produce Incorrect Results

    Incorrect test results may occur for the following antibiotics: Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone. The test may report certain bacteria as sensitive to one of these antibiotics when the bacteria are actually resistant. Rapid Neg BP Combo Panel Type 3 and Rapid Neg Urine Combo Panel Type 1 devices can identify certain gram negative bacteria and measure how these bacteria (Enterobacteriaceae, Acinetobacter species, and Pseudomonas aeruginosa) respond to antibiotics such as Aztreonam, Cefotaxime, Ceftazidime, and Ceftriaxone in the laboratory. On October 17, 2014 and again on November 7, 2014 the firm sent Urgent Medical Device Recall letters to their customers stating the problem and the steps to be taken. Customers who have these recalled devices in their inventory should stop using the recalled devices, discard any remaining products in inventory, complete and return the Field Correction Effectiveness Check that is attached to the Urgent Medical Device Recall letter, and forward the Urgent Medical Device Recall letters to others who may have received the recalled devices.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm425288.htm

    Sterile Convenience Kits

    On October 8, 2014 Customed, Inc. initiated a recall of sterile convenience surgical kits-trays, bags (known as “Convenience Kits”), and New Lots Added as follow-up to the June 3, 2014 Class I recall of 233 sterile convenience surgical kits. The Convenience Kits have a potential package integrity defect that may compromise the sterility of the product, as well as serious deficiencies in manufacture and storage of the products that may significantly affect the risk of contamination and resultant infection.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm424718.htm

    FDA Alerts

    Feng Shi Ling

    The FDA is advising consumers not to purchase or use “Feng Shi Ling,” a product promoted and sold as an herbal medication for arthritic pain associated with rheumatoid arthritis and osteoporosis. The product is manufactured by Hong Kong Chi Chun Tang Herbal Factory. FDA laboratory analysis found that “Feng Shi Ling” contains the undeclared active ingredients diclofenac and indomethacin.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm424103.htm

    Laparoscopic Power Morcellation in Hysterectomy and Myomectomy

    The FDA is warning against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women. In an Immediately in Effect guidance, the FDA is also recommending that manufacturers of laparoscopic power morcellators include in their product labeling specific safety statements in the form of a boxed warning and two contraindications.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm393809.htm

    Long-Term Antiplatelet Therapy

    FDA is evaluating preliminary data from a clinical trial showing that treatment for 30 months with dual antiplatelet blood-thinning therapy decreased the risk of heart attacks and clot formation in stents, but there was an increased overall risk of death compared to 12 months of treatment. The clinical trial compared 30 months versus 12 months of treatment with dual antiplatelet therapy consisting of aspirin plus either clopidogrel (Plavix) or prasugrel (Effient), following implantation of drug-eluting coronary stents.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm423165.htm

    Methylphenidate Hydrochloride Extended-Release Tablets

    Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended-release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd. The FDA has not identified any serious safety concerns with these two generic products. Patients should not make changes to their treatment except in consultation with their healthcare professional.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm422568.htm

    Multi-function Defibrillation Electrodes

    Heart Sync Inc. notified customers of a Voluntary Urgent Device Correction for certain Multi-function Defibrillation Electrodes due to a connector compatibility issue with Philips FR3 and FRx Defibrillator Units. These electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discover the incompatibility issue until the AED must be used. The affected multi-function electrodes were distributed globally to distributors and medical facilities from October 26, 2011 through November 26, 2014. There are a total of 113,750 electrodes affected by this voluntary device correction.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm425605.htm

    Pregnancy and Lactation Labeling Information

    The FDA published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products. The new content and formatting requirements will provide a more consistent way to include relevant information about the risks and benefits of prescription drugs and biological products used during pregnancy and breastfeeding. The final rule replaces the current product letter categories—A, B, C, D, and X—used to classify the risks of using prescription drugs during pregnancy with three detailed subsections that describe risks within the real-world context of caring for pregnant women who may need medication.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm425317.htm


    FDA is warning that a patient with multiple sclerosis who was being treated with Tecfidera (dimethyl fumarate) developed a rare and serious brain infection called progressive multifocal leukoencephalopathy (PML), and later died. The patient who died was not taking any other drugs that affect the immune system or drugs that are thought to be associated with PML. As a result, information describing this case of PML is being added to the Tecfidera drug label.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm424752.htm