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  • FDA Drug Updates

    FDA New Approvals


    Suneva Medical, Inc. announced that the FDA has approved the dermal filler, Bellafill, for the treatment of acne scars. Bellafill was studied extensively prior to its FDA approval and proven to be safe and effective for the correction of moderate to severe, atrophic, distensible facial acne scars on the cheek in patients over the age of 21 years.
    For more information, visit: www.sunevamedical.com/bellafill-receives-fda-approval-for-treatment-of-acne-scars


    Hospira, Inc. has received approval from the FDA for Dyloject (diclofenac sodium) Injection, a proprietary nonsteroidal anti-inflammatory drug analgesic. Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics.
    For more information, visit: phx.corporate-ir.net/phoenix.zhtml?c=175550&p=irol-newsArticle&ID=2002298

    EnLite Neonatal TREC Kit

    The FDA has allowed marketing of the EnLite Neonatal TREC Kit, the first screening test permitted to be marketed by the FDA for severe combined immunodeficiency in newborns. The EnLite Neonatal TREC Kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426962.htm

    Fluzone Intradermal Quadrivalent

    Sanofi Pasteur, the vaccines division of Sanofi, announced that the FDA has approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus. Fluzone Intradermal Quadrivalent vaccine is indicated for adults 18 through 64 years of age for active immunization for the prevention of influenza caused by influenza A subtype viruses and type B viruses contained in the vaccine.
    For more information, visit: sanofipasteurus.mediaroom.com/2014-12-12-Sanofi-Pasteur-Announces-FDA-Approval-of-Fluzone-Intradermal-Quadrivalent-Influenza-Vaccine-for-Adults

    Gardasil 9

    Merck announced that the FDA approved Gardasil 9 (human papillomavirus 9-valent vaccine, recombinant), Merck’s 9-valent human papillomavirus (HPV) vaccine, for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58, pre-cancerous 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 also approved for use in boys 9 to 15 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.
    For more information, visit: www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-hpv-vaccine-gardasil9-prevent-cancers-an

    Intercept Blood System for Plasma

    The FDA has approved the Intercept Blood System for plasma. The Intercept Blood System for plasma may be used to reduce pathogens in plasma derived from whole blood and plasma obtained by apheresis, a collection process that separates red blood cells from plasma and then returns the red cells to the donor.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427111.htm

    Intercept Blood System for Platelets

    The FDA has approved the Intercept Blood System for platelets, the first pathogen reduction system to treat single donor apheresis platelets. The system is for use by blood establishments that collect and manufacture blood and blood components to prepare pathogen-reduced platelets for transfusion to reduce the risk of transfusion-transmitted infections.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427500.htm

    Kitabis Pak

    The FDA has approved PulmoFlow, Inc.'s Kitabis Pak, a co-packaging of generic tobramycin inhalation solution with a PARI LC PLUS Nebulizer, for the management of cystic fibrosis in adults and pediatric patients 6 years of age and older with Pseudomonas aeruginosa.
    For more information, visit: www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205433Orig1s000TAltr.pdf


    AstraZeneca announced that the FDA has approved Lynparza (olaparib) capsules (400mg twice daily) as monotherapy for patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer, who have been treated with three or more prior lines of chemotherapy.
    For more information, visit: www.astrazeneca.com/Media/Press-releases/Article/20141219--lynparza-approved

    MP Diagnostics HTLV Blot 2.4

    The FDA has approved MP Diagnostics HTLV Blot 2.4, the first FDA-licensed supplemental test for Human T-cell Lymphotropic Virus-I/II (HTLV-I/II). This test is intended for use as an additional, more specific test for human serum or plasma specimens that have previously tested positive on an FDA-licensed HTLV-I/II blood donor screening test. The MP Diagnostics HTLV Blot 2.4 is a qualitative enzyme immunoassay test intended to confirm infection with HTLV and to differentiate between HTLV-I and HTLV-II. MP Diagnostics HTLV Blot 2.4 is manufactured by MP Biomedicals Asia Pacific Pte. Ltd. Singapore, a company of MP Biomedicals LLC.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426605.htm


    Actavis and Adamas Pharmaceuticals Inc. announced that the FDA has approved the New Drug Application for Namzaric, a fixed-dose combination of memantine hydrochloride extended-release, an NMDA receptor antagonist, and donepezil hydrochloride, an acetylcholinesterase inhibitor. Namzaric was approved for the treatment of moderate to severe dementia of the Alzheimer's type in patients stabilized on memantine hydrochloride and donepezil hydrochloride. Actavis expects to launch Namzaric in the United States in the second quarter of 2015.
    For more information, visit: www.actavis.com/news/news/thomson-reuters/actavis-and-adamas-announce-fda-approval-of-namzar


    Bristol-Myers Squibb Company announced that the FDA approved Opdivo (nivolumab) injection, for intravenous use. Opdivo is a human programmed death receptor-1 blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.
    For more information, visit: news.bms.com/press-release/bristol-myers-squibb-receives-accelerated-approval-opdivo-nivolumab-us-food-and-drug-a

    PLAC Test for Lp-PLA2 Activity

    The FDA cleared a new screening test that predicts a patient’s risk of future coronary heart disease events, such as heart attacks. The FDA cleared the test for use in all adults with no history of heart disease, but studies submitted by the company and reviewed by the FDA show that the test is better at discerning this risk in women, particularly black women.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm426799.htm


    BioCryst Pharmaceuticals, Inc. announced that the FDA has approved Rapivab (peramivir injection), an intravenous neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.
    For more information, visit: investor.shareholder.com/biocryst/releasedetail.cfm?ReleaseID=888601


    Impax Pharmaceuticals announced that the FDA approved Rytary, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and/or manganese intoxication. Impax expects the four strengths of Rytary, 23.75mg/95mg, 36.25mg/145mg, 48.75mg/195mg, and 61.25mg/245mg (carbidopa/levodopa) to be available for commercial distribution in February 2015.
    For more information, visit: investors.impaxlabs.com/Media-Center/Press-Releases/Press-Release-Details/2015/Impax-Pharmaceuticals-Announce-FDA-Approval-of-RYTARY-Carbidopa-and-Levodopa-Extended-Release-Capsules-for-the-Treatment-of-Parkinsons-disease/default.aspx


    Daiichi Sankyo Company announced that the FDA has approved Savaysa (edoxaban) Tablets, an oral, once-daily selective factor Xa-inhibitor, to reduce the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation. The FDA also approved Savaysa for the treatment of deep vein thrombosis and pulmonary embolism following 5–10 days of initial therapy with a parenteral anticoagulant.
    For more information, visit: www.daiichisankyo.com/media_investors/media_relations/press_releases/detail/006236.html


    Novo Nordisk announced that the FDA has approved the New Drug Application for Saxenda (liraglutide [rDNA origin] injection), a once-daily glucagon-like peptide-1 receptor agonist for chronic weight management. Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI ≥30kg/m2) or who are overweight (BMI ≥27kg/m2) in the presence of at least one weight-related comorbid condition. Novo Nordisk expects to launch Saxenda in the United States in the first half of 2015.
    For more information, visit: press.novonordisk-us.com/index.php?s=20295&item=122801

    Signifor LAR

    Novartis announced that the FDA has approved Signifor long-acting release (pasireotide) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.
    For more information, visit: www.novartis.com/newsroom/media-releases/en/2014/1880449.shtml

    Somatuline Depot

    Ipsen announced that Somatuline Depot (lanreotide) Injection 120mg (referred to as Somatuline) was approved by the FDA for the treatment of adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors.
    For more information, visit: www.ipsen.com/wp-content/uploads/2014/12/12-2014-corporate-PR-Approval-Somatuline-US-FINAL.pdf


    Galderma Laboratories, L.P. announced that the FDA approved Soolantra (ivermectin) Cream, 1% for the once-daily topical treatment of inflammatory lesions, or bumps and pimples, of rosacea.
    For more information, visit: www.galdermausa.com/downloads/FDA%20Approval%20Press%20Release_FINAL_12%2022%2014.pdf

    Viekira Pak

    The FDA has approved AbbVie's Viekira Pak, an all-oral, interferon-free treatment, with or without ribavirin, for the treatment of patients with chronic genotype 1 hepatitis C virus infection, including those with compensated cirrhosis. Viekira Pak contains three distinct mechanisms of action—an NS5A inhibitor, an NS3/4A protease inhibitor, and a non-nucleoside NS5B polymerase inhibitor—that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.
    For more information, visit: abbvie.mediaroom.com/2014-12-19-AbbVie-Receives-U-S-FDA-Approval-of-VIEKIRA-PAK-Ombitasvir-Paritaprevir-Ritonavir-Tablets-Dasabuvir-Tablets-for-the-Treatment-of-Chronic-Genotype-1-Hepatitis-C


    The FDA has approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Xtoro is an eardrop approved to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus. Xtoro is manufactured Alcon Laboratories, Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427274.htm


    Cubist Pharmaceuticals, Inc. announced that the FDA approved Zerbaxa (ceftolozane/tazobactam) for the treatment of adults with complicated urinary tract infections and complicated intra-abdominal infections caused by designated susceptible Gram-negative bacteria.
    For more information, visit: www.cubist.com/media/news-releases/cubist-announces-fda-approval-of-new-antibiotic-ze

    FDA New Dosage Strengths


    Orexo AB announced that it has received approval from the FDA of two higher dosage strengths of Zubsolv (buprenorphine/naloxone CIII sublingual tablet) for maintenance treatment of opioid dependence. The new dosage strengths are 8.6mg/2.1mg and 11.4mg/2.9mg buprenorphine/naloxone CIII sublingual tablets. The 8.6mg/2.1mg dosage strength is expected to be launched early 2015 and the 11.4mg/2.9mg strength later in 2015.
    For more information, visit: www.orexo.com/en/Investor-Relations/Press-releases/?guid=959626

    FDA New Indications


    Eli Lilly and Company has received its third FDA approval for Cyramza (ramucirumab). Specifically, Cyramza is now also indicated in combination with docetaxel, for the treatment of patients with metastatic non-small cell lung cancer with disease progression on or after platinum-based chemotherapy.
    For more information, visit: investor.lilly.com/releasedetail.cfm?ReleaseID=887944


    Jazz Pharmaceuticals announced that the FDA approved the intravenous administration of Erwinaze (asparaginase Erwinia chrysanthemi). Erwinaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of patients with acute lymphoblastic leukemia who have developed hypersensitivity to Escherichia coli-derived asparaginase. Prior to this approval, the only approved route of administration for Erwinaze was through intramuscular injection.
    For more information, visit: investor.jazzpharma.com/phoenix.zhtml?c=210227&p=irol-newsArticle&ID=2001288


    Bayer HealthCare announced that the FDA has approved Gadavist (gadobutrol) Injection for use with magnetic resonance imaging in pediatric patients less than 2 years of age, including term neonates, to detect and visualize areas with disrupted blood-brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was previously approved for this use in patient populations over the age of 2.
    For more information, visit: press.healthcare.bayer.com/en/press/news-details-page.php/15726/2015-0004


    Teva Pharmaceutical Industries Ltd. announced that the FDA has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. Granix, a leukocyte growth factor, is indicated for reduction in the duration of severe neutropenia in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.
    For more information, visit: www.tevapharm.com/Media/News/Pages/2014/2001794.aspx


    Vertex Pharmaceuticals Incorporated has announced that the FDA approved a supplemental New Drug Application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis (CF) ages 6 and older who have the R117H mutation in the CF transmembrane conductance regulator gene. Kalydeco is now approved for use in the United States in people ages 6 and older with CF with one of the following ten mutations: R117H, G551D, G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P, or G1349D.
    For more information, visit: investors.vrtx.com/releasedetail.cfm?ReleaseID=889027


    Amgen has announced that the FDA has approved a new indication for Xgeva (denosumab) for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Xgeva was approved in 2010 by the FDA for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
    For more information, visit: www.amgen.com/media/media_pr_detail.jsp?year=2014&releaseID=1995709

    FDA Recalls

    0.9% Sodium Chloride Injection USP in 100mL MINI-BAG PLUS Container

    Baxter International Inc. initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100mL MINI-BAG PLUS Container to the hospital/user level. The recall is being initiated as a result of two complaints (one per lot) of particulate matter that was identified as a fragment of the frangible from the vial adapter. This recall affects lot numbers P317842 and P317891.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm426996.htm

    B-Lipo Capsules

    Bethel Nutritional Consulting, Inc. is recalling one lot of B-Lipo Capsules to the consumer level. The firm was informed by the FDA that a sample of B-Lipo Capsules collected and tested by the FDA was found to contain lorcaserin, a controlled substance used for weight loss. B-Lipo Capsules are marketed as a natural herbal supplement for weight loss. B-Lipo burgundy and white capsules are packaged in white plastic bottles containing 30 capsules per bottle, and labeled with Lot # 20213 EXP DATE 12/22/2016, and bar code 160126 417509.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm427657.htm

    KimVent Microcuff Subglottic Suctioning Endotracheal Tubes

    The cuff inflation line of certain KimVent Microcuff Endotracheal tubes may detach from the tube during use (if pulled, tugged, or excess tube/patient movement occurs). If the inflation line detaches, the cuff will gradually deflate. This may lead to an air leak between the cuff and the tracheal wall, which in turn may reduce the amount of air that reaches the lungs. This recall affects device manufacturing dates November 15, 2013 to October 21, 2014, and distribution dates December 20, 2013 to October 30, 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm428654.htm


    Hospira, Inc. announced it has initiated a worldwide voluntary recall to the user level of 10 lots of Mitoxantrone (both human and veterinary), due to confirmed subpotency and elevated impurity levels. Risk factors associated with these types of out of specifications may include the potential for decreased potency, which can lead to decreased effectiveness, additional dosing, and the potential for cumulative impurity toxicity requiring medical intervention. Affected lots were distributed to hospitals and veterinary clinics worldwide from February 2013 through November 2014.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm427967.htm

    Nellcor Puritan Bennett 980 Ventilator System

    Part of the Nellcor Puritan Bennett 980 Ventilator System circuit board may have cracks due to problems in the manufacturing process. The cracks can cause the ventilator’s display screen to dim and give off a burning smell. There is no risk of fire due to this issue, but the part needs to be replaced so information on the display screen will be visible.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm428603.htm

    SLIM-K Capsules

    Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level. The firm was informed by the FDA that a sample of SLIM-K collected and tested by the FDA was found to contain sibutramine, desmethylsibutramine, and phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the United States market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia, and strokes). Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States. SLIM-K Capsules are marketed as a natural herbal supplement for weight loss. SLIM-K blue and white capsules are packaged in white plastic bottles containing 30 capsules per bottle, and labeled with Lot # 140430, Expiration 12/2017, and barcode 160126417509.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm427662.htm


    Valeant Pharmaceuticals North America LLC is issuing a voluntarily recall of one lot of Virazole (ribavirin powder for solution), 100mL, 6g vial, 4-pack to the user level. The affected Virazole lot is Lot No. 340353F with an expiration date of Oct-2018. Virazole was distributed in the United States and Australia.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm428683.htm

    FDA Alerts

    Alere INRatio2 PT/INR Professional Test Strips

    Alere Inc. initiated a voluntary correction to inform United States users of the Alere INRatio and INRatio2 PT/INR Monitor system of certain medical conditions that should not be tested with the system (INRatio Monitor or INRatio2 Monitor and INRatio Test Strips). In certain cases, an INRatio and INRatio2 PT/INR Monitor system may provide an INR result that is clinically significantly lower than a result obtained using a reference INR system (laboratory method). This issue can arise if the patient has certain medical conditions or can occur if the instructions in the labelling for performing the test are not followed.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm396324.htm

    Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons

    The FDA is warning health professionals of the risks associated with the use of dietary supplements containing live bacteria or yeast in immunocompromised persons. A premature infant administered a dietary supplement, ABC Dophilus Powder (Solgar), as part of an in-hospital course of treatment, developed gastrointestinal mucormycosis caused by the mold Rhizopus oryzae and died. R. oryzae mold was found to be present as a contaminant in an unopened container of the ABC Dophilus Powder, which is formulated to contain three species of live bacteria.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm426331.htm

    Wallcur IV Solutions

    The FDA is alerting healthcare professionals not to use Wallcur, LLC, simulated intravenous products in human or animal patients. These products are for training purposes only. There have been reports of serious adverse events associated with the use of certain of these products.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm428496.htm


    The FDA is warning that the antipsychotic drug ziprasidone (marketed under the brand name, Geodon, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. A new warning has been added to the Geodon drug label to describe the serious condition known as drug reaction with eosinophilia and systemic symptoms (DRESS).
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm426624.htm