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  • FDA Drug Updates

    FDA New Approvals


    Flamel Technologies has announced that the FDA has approved the company's new drug application for Bloxiverz (neostigmine methylsulfate), a drug used intravenously in the operating room for the reversal of the effects of non-depolarizing neuromuscular blocking agents after surgery. Bloxiverz is the first FDA-approved version of neostigmine, even though other versions of neostigmine have been on the market as unapproved, grandfathered products under the Food, Drug, and Cosmetic Act of 1938. Flamel expects to launch Bloxiverz in July 2013 in 0.5 and 1.0 mg/mL strengths.
    For more information, visit: www.flamel.com/investors/?view=flamel-technologies-announces-fda-approval-of-bloxiverz-56a57fbbaf1b4a07d64d353870f2dc8ff9b42102

    Breo Ellipta

    The FDA has approved Breo Ellipta (fluticasone furoate and vilanterol inhalation powder) for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also approved to reduce exacerbations of COPD in patients with a history of exacerbations. Breo Ellipta is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist (LABA). Breo Ellipta works by decreasing inflammation in the lungs and helping the muscles around the airways of the lungs stay relaxed to increase airflow and reduce exacerbations in patients with COPD. The drug carries a boxed warning that LABAs increase the risk of asthma-related death. The safety and efficacy of Breo Ellipta in patients with asthma have not been established, and it is not approved for the treatment of asthma. Breo Ellipta was developed by GlaxoSmithKline in collaboration with Theravance.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm351664.htm

    Cobas Integra 800 Tina-quant HbA1cDx Assay

    The FDA has announced that it is allowing marketing of the Cobas Integra 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of diabetes by healthcare professionals. This is the first HbA1c test that the FDA has allowed to be marketed for this use. The HbA1c tests, or A1c tests, currently on the market are FDA-cleared for monitoring a patient’s blood glucose control, but not for diagnosing diabetes. The Tina-quant HbA1cDX assay is available by prescription for use in clinical laboratories. Hemoglobin A1c tests, including the Tina-quant HbA1cDx assay, should not be used to diagnose diabetes during pregnancy and should not be used to monitor diabetes in patients with hemoglobinopathy, hereditary spherocytosis, malignancies, or severe chronic, hepatic and renal disease. This test should not be used to diagnose or monitor diabetes in patients with the hemoglobin variant hemoglobin F. The Tina-quant HbA1cDx assay is manufactured by Roche.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353653.htm

    Fluzone Quadrivalent Vaccine

    Sanofi Pasteur, the vaccines division of Sanofi, announced that the FDA has approved the supplemental biologics license application for licensure of its four-strain influenza vaccine, Fluzone Quadrivalent vaccine. Fluzone Quadrivalent vaccine is licensed for use in children 6 months of age and older, adolescents, and adults. The 2013 influenza season will be the first in which quadrivalent influenza vaccines will be available in the US. Fluzone Quadrivalent vaccine will be available to healthcare providers in the US for the 2013-2014 influenza season in prefilled syringes and single-dose vials for intramuscular administration.
    For more information, visit: sanofipasteurus.mediaroom.com/2013-06-10-New-Four-Strain-Influenza-Vaccine-from-Sanofi-Pasteur-Now-Licensed-By-FDA-for-Broad-Age-Range-of-Children-and-Adults


    The FDA has approved Nymalize, a new nimodipine oral solution, to treat patients experiencing symptoms resulting from subarachnoid hemorrhage. Nimodipine previously was available only as a liquid-filled gel capsule. Over the years, the FDA has received reports of serious and sometimes fatal consequences from IV injection of the liquid contents of oral nimodipine capsules. IV administration of nimodipine meant for oral use can result in death, cardiac arrest, severe decreases in blood pressure, and other heart-related complications. In August 2010, the agency reminded healthcare professionals about the risks of IV administration of nimodipine from oral capsules, and in 2006, a Boxed Warning was added to the drug to warn against such use. Based on the potential of the oral formulation, Nymalize, to decrease or eliminate medication errors, the application received fast track designation and priority review. Nymalize is made by Arbor Pharmaceuticals Inc.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352280.htm

    Tafinlar and Mekinist

    The FDA has approved two new drugs, Tafinlar (dabrafenib) and Mekinist (trametinib), for patients with metastatic or unresectable melanoma. Tafinlar, a BRAF inhibitor, is approved to treat patients with melanoma whose tumors express the BRAF V600E gene mutation. Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations. Approximately half of melanomas arising in the skin have a BRAF gene mutation. Tafinlar and Mekinist are being approved as single agents, not as a combination treatment. The FDA approved Tafinlar and Mekinist with a genetic test called the THxID BRAF test, a companion diagnostic that will help determine if a patient’s melanoma cells have the V600E or V600K mutation in the BRAF gene. Tafinlar and Mekinist are marketed by GlaxoSmithKline. The THxID BRAF Kit is manufactured by bioMérieux.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htm


    The FDA has approved Xofigo (radium Ra 223 dichloride) to treat men with symptomatic late-stage (metastatic) castration-resistant prostate cancer that has spread to bones but not to other organs. It is intended for men whose cancer has spread after receiving medical or surgical therapy to lower testosterone. The FDA reviewed Xofigo under the agency’s priority review program, which provides for an expedited review of drugs that appear to provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to marketed products. The most common side effects reported during clinical trials in men receiving Xofigo were nausea, diarrhea, vomiting, and swelling of the leg, ankle, or foot. The most common abnormalities detected during blood testing included anemia, lymphocytopenia, leukopenia, thrombocytopenia, and neutropenia. Xofigo is marketed by Bayer Pharmaceuticals.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352363.htm

    FDA New Indications


    Novartis has announced that the FDA has approved Ilaris (canakinumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients aged 2 years and older. Ilaris is the first interleukin-1 beta inhibitor approved for SJIA and the only treatment approved specifically for SJIA that is given as a once-monthly subcutaneous injection.
    For more information, visit: www.pharma.us.novartis.com/newsroom/pressreleases/Ilaris05102013.shtml


    Celgene Corporation announced that the FDA has approved the company’s supplemental new drug application for Revlimid (lenalidomide) for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
    For more information, visit: newsroom.celgene.com/press-release/corporate/us-food-and-drug-administration-approves-revlimid-lenalidomide-treatment-pat


    The FDA has approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis. Previously approved to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, Simponi is now approved to treat adults with moderate to severe ulcerative colitis that is resistant (refractory) to prior treatment or requires continuous steroid therapy.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm352383.htm


    The FDA has approved Tarceva (erlotinib) for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations. This indication for erlotinib is being approved concurrently with the cobas EGFR Mutation Test, a companion diagnostic test for patient selection. The recommended daily dose of erlotinib for NSCLC is 150 mg taken orally at least one hour before or two hours after the ingestion of food. Treatment should continue until disease progression or unacceptable toxicity.
    For more information, visit: www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm352317.htm

    FDA First-Time Generic Approval

    Candesartan Cilexetil

    Sandoz announced the FDA approval and US launch of candesartan cilexetil tablets, the first generic version of Atacand. Candesartan cilexetil tablets are indicated to treat some types of heart failure in adults with left ventricular systolic dysfunction, and hypertension in adults and children 1 to 17 years of age. They may be used alone or in combination with other antihypertensive agents. Sandoz is marketing candesartan cilexetil tablets in 4 mg, 8 mg, 16 mg, and 32 mg strength tablets, which are the same strengths marketed for Atacand.
    For more information, visit: www.sandoz.com/media_center/news/2013/press_releases/2013_05_22_atacand.shtml

    FDA Recalls

    Certain Compounded Prescription Therapies from Pentec Health, Inc.

    Pentec Health, Inc. has decided to initiate a limited, voluntary recall of in-date nutritional prescriptions for renal patients due to lack of sterility assurance associated with one of its laminar flow hoods used in compounding. The recall covers renal therapies that were compounded in this hood on or before May 2, 2013. These therapies were supplied to renal dialysis centers and directly to patients. Pentec Health is directly notifying each dialysis center and in-home dialysis patient of the recall. Prescriptions for a total of 163 patients are included in the scope of this recall. Pentec Health has received no reports of injury or illness associated with any of the prescriptions subject to this recall. Sterility tests associated with the compounding hood involved, as well as testing of finished products made in the hood, have shown sterility. However, in an abundance of caution, because patients are at increased risk of infection in the event a sterile product is compromised, the pharmacy is recalling any unused product whose beyond-use date has not passed.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm352861.htm

    EZ Breathe Atomizer

    The EZ Breathe Atomizer is a device that is intended to spray liquid medication in aerosol form into the air that a person will breathe. A Medical Device Recall was issued due to a manufacturing defect which could result in the washer ("Plate A") becoming dislodged from the EZ Breathe Atomizer. If this occurs, users may accidentally swallow the washer or choke on it, which can lead to serious adverse health consequences or death. Devices were distributed between August 2012 and April 2013. The EZ Breathe Atomizer is manufactured by Health & Life Co., LTD and sold to Nephron Pharmaceuticals Corporation. Nephron Pharmaceuticals Corporation distributes the EZ Breathe Atomizer for sale and use in the Asthmanefrin Starter Kit. The EZ Breathe Atomizer was also sold by Nephron Pharmaceuticals Corporation as an individual device in a carton labeled EZ Breathe Atomizer, Model #EZ-100.
    For more information, visit: www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm355037.htm

    GoPump Rapid Recovery System Kits and GOBlock Kits

    Symbios Medical Products initiated a voluntary recall of all GoPump Rapid Recovery System kits and GOBlock Kits manufactured with flow control components assembled prior to July 2012. These products have been found to potentially cause excessively high flow rates, which presents a risk of patient toxicity and serious injury (eg, seizure, dysrhythmia, death) due to the rapid influx of medication, particularly in patients with low body mass or advanced age. To date, there have been 5 complaints received, 2 of which involved serious consequences. There have been no patient deaths reported. The root cause is understood and processes have been put in place to address the issue. This recall affects only the 50 United States plus the District of Columbia. Distributors and clinical provider sites using these Symbios Medical Products have been notified of the affected product codes and lot numbers. Symbios is working to secure all affected product and have it returned. Products subject to this recall were distributed between April 1, 2011 and April 30, 2013.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm352627.htm

    Lowlite Investments Sterile Drug Products

    Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") has announced a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In the event a sterile product is compromised, patients are at risk for serious and possible life threatening infections. To date, Lowlite has received no reports of injury or illness associated with the use of its sterile products. This voluntary recall is being conducted as a precautionary measure to ensure the sterility of their sterile products, and is being conducted with the full knowledge of the FDA. The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm354450.htm

    Magnesium Sulfate

    Fresenius Kabi USA announced that it has initiated a voluntary recall of one lot—Lot 6103882—of Magnesium Sulfate Injection, USP, due to the potential presence of glass particles in the vials. The recall is a precautionary measure, following a routine company inspection of retained product samples. No adverse events, patient reactions, or customer complaints have been reported to date. All customers who received the recalled vials are being notified and instructed to return any unused product to their supplier. The recalled product is labeled with Product Code 6450 and packaged as 500 mg/mL strength in 50 mL glass vials (25 vials per tray). The product was shipped in the US between May 30, 2012 and June 6, 2012 and has an expiration date of October 31, 2014.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm354238.htm

    Main Street Family Pharmacy in Tennessee

    The FDA is working closely with the Centers for Disease Control and Prevention (CDC) and Tennessee Board of Pharmacy to investigate reports of seven adverse events associated with steroid injections compounded by Main Street Family Pharmacy, LLC (Main Street) of Newbern, Tennessee. Out of an abundance of caution, the FDA recommends that healthcare providers not administer any products labeled as sterile from Main Street and quarantine them until further guidance is provided. The reports of adverse events are all from patients who received preservative-free methylprednisolone acetate (80 mg/mL) by injection. To date, the FDA has received seven reports. Clinical information about these patients is pending; at least one of these adverse events appears to involve fungus. An investigation into the exact source of these adverse events is still ongoing, but these cases are associated with a potentially contaminated medication. As part of the ongoing investigation, the FDA will continue to work closely with the CDC and state authorities to thoroughly review the sterile practices at Main Street.
    For more information, visit: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm353941.htm

    Methotrexate Sodium

    Sandoz is conducting a voluntary nationwide recall to the hospital/user level of two lots of its Methotrexate Sodium, USP, 25 mg/mL, 40 mL vial injectable product in the US, due to the discovery of particulate matter in vials during routine quality examination of retention samples at the manufacturer. The product is preservative free. The particulates are not associated with microbial contamination. Particulate matter in parenteral drugs has been recognized as a potential health hazard. Parenteral injection of drug from the affected lots can lead to microembolisation in areas where the particles lodge. Following IV injections, this is in all likelihood the lung. Intrathecal injections are very unlikely with the affected product. In the event of intrathecal administration, areas of particle lodging are most likely the areas of spinal fluid resorption. Clinical symptoms are not to be expected from these microemboli. Sandoz is not aware of any reports of related adverse events. The lot numbers and expiration dates of the two recalled lots are: CL0996 (expiration date 12/2013) and CJ4948 (expiration date 05/2013). These lots were distributed nationally across the US.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm353291.htm

    The Compounding Shop

    The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection. In the event a sterile product is compromised, patients are at risk for very serious infections. To date, The Compounding Shop has received no reports of injury or illness associated with the use of its sterile products. However, out of the abundance of caution and in the interest of the pharmacy's patients, The Compounding Shop has decided to voluntarily proceed with this recall process and to cease production of sterile products until further notice. These products were supplied to the offices of licensed medical professionals and to patients by prescription within the pharmacy's local market area. The Compounding Shop is notifying its customers by fax, phone, or email to return products to the pharmacy.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm351841.htm

    Vecuronium Bromide for Injection 10 mg

    Sagent Pharmaceuticals, Inc. has announced the voluntary nationwide recall of three lots of Vecuronium Bromide for Injection 10 mg (NDC number 25021-657-10) manufactured by Mustafa Nevzat Ilac Sanayii A.S. (MN Pharmaceuticals) and distributed by Sagent. Sagent has initiated this voluntary recall of Vecuronium Bromide for Injection to the user level due to the discovery of an elevated impurity result detected during routine quality testing of stability samples at the 18-month interval. The elevated impurity result has the potential to result in prolonged neuromuscular blockade for critically ill patients with renal failure. Sagent is not aware of any adverse patient events resulting from the use of this product and is continuing its diligent investigation of the situation. The lot numbers being recalled are 11I30481A, 11I30721A, and 11I32581A, which were distributed to hospitals, wholesalers, and distributors nationwide from January 2012 through May 2012.
    For more information, visit: www.fda.gov/Safety/Recalls/ucm356010.htm

    FDA Alerts

    Magnesium Sulfate

    The FDA is advising healthcare professionals against using magnesium sulfate injection for more than 5-7 days to stop pre-term labor in pregnant women. This use of the drug is off-label, which means that it is not an FDA-approved use of the drug. Administration of magnesium sulfate injection to pregnant women longer than 5-7 days may lead to low calcium levels and bone problems in the developing baby or fetus, including thin bones, called osteopenia, and bone breaks, called fractures. The shortest duration of treatment that can result in harm to the baby is not known. Magnesium sulfate is approved to prevent seizures in preeclampsia, a condition in which the pregnant woman develops high blood pressure and protein in the urine, and for control of seizures in eclampsia. In light of this new safety information about low calcium levels and bone problems in the developing baby, new information is being added to the drug label for Magnesium Sulfate Injection, USP 50%.
    For more information, visit: www.fda.gov/downloads/Drugs/DrugSafety/UCM353335.pdf

    Zolpidem Products

    The FDA is notifying the public that the FDA has approved label changes specifying new dosing recommendations for zolpidem products (Ambien, Ambien CR, and Edluar). The FDA has approved these changes because of the known risk of next-morning impairment with these drugs. The FDA is also warning that patients who take the sleep medication zolpidem extended-release (Ambien CR)―either 6.25 mg or 12.5 mg―should not drive or engage in other activities that require complete mental alertness the day after taking the drug, because zolpidem levels can remain high enough the next day to impair these activities. This new recommendation has been added to the Warnings and Precautions section of the physician label and to the patient Medication Guide for zolpidem extended-release (Ambien CR). Also included in the updated label are the dosing recommendations previously stated in the FDA’s January 2013 Drug Safety Communication: The recommended initial dose of certain immediate-release zolpidem products (Ambien and Edluar) is 5 mg for women and either 5 mg or 10 mg for men. The recommended initial dose of zolpidem extended-release (Ambien CR) is 6.25 mg for women and either 6.25 or 12.5 mg for men. If the lower doses (5 mg for immediate-release, 6.25 mg for extended-release) are not effective, the dose can be increased to 10 mg for immediate-release products and 12.5 mg for zolpidem extended-release. However, use of the higher dose can increase the risk of next-day impairment of driving and other activities that require full alertness.
    For more information, visit: www.fda.gov/Drugs/DrugSafety/ucm352085.htm