FDA New Approvals
Alere i Strep A Test
Alere Inc. has announced that its Alere i Strep A test has received marketing clearance from the FDA. Alere i Strep A is the first molecular test that detects Group A Streptococcus bacteria in throat swab specimens in 8 minutes or less.
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Emergent BioSolutions has announced that the FDA has approved Anthrasil [Anthrax Immune Globulin Intravenous (Human)], also known as AIGIV, for treatment of inhalational anthrax in combination with appropriate antibacterial drugs. Anthrasil has received Orphan Drug designation and as a result of this approval, the product qualifies for 7 years of market exclusivity.
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Retrophin, Inc. announced that the FDA has approved Cholbam (cholic acid) capsules, for pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders (including Zellweger spectrum disorders).
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Gastric Emptying Breath Test
The FDA has approved the Gastric Emptying Breath Test (GEBT), a new non-invasive test to aid in the diagnosis of delayed gastric emptying, known as gastroparesis. The GEBT, conducted over a 4-hour period after an overnight fast, is designed to show how fast the stomach empties solids by measuring carbon dioxide in a patient’s breath.
Learn more about the Gastric Emptying Breath Test
Impella 2.5 System
The FDA has approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain high-risk percutaneous coronary intervention procedures, such as balloon angioplasty and stenting, which reopen coronary arteries that are narrowed or blocked due to severe coronary artery disease.
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Novartis announced that the FDA has approved Jadenu (deferasirox) tablets, a new oral formulation of Exjade (deferasirox) tablets for oral suspension, for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older, and chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients 10 years of age and older.
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Lixelle Beta 2-microglobulin Apheresis Column
The FDA has authorized use of the Lixelle Beta 2-microglobulin Apheresis Column, the first device to treat dialysis-related amyloidosis. The Lixelle Column works by removing beta 2-microglobin from the blood. It contains porous cellulose beads specifically designed to bind to beta 2-microglobulin as the patient’s blood passes over the beads. The device is used in conjunction with hemodialysis.
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Teva Pharmaceutical Industries Ltd. announced that the FDA has approved ProAir RespiClick (albuterol sulfate) inhalation powder, a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm in patients 12 years of age and older. It is expected to become commercially available to patients during the second quarter of 2015.
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Radiesse (+) with Integral 0.3% Lidocaine
Merz North America, US affiliate of the global Merz Pharma Group, announces that Radiesse (+) with integral 0.3% Lidocaine (“Radiesse Plus”) has received FDA approval and is now available to US physicians. Radiesse (+) provides the immediate lift of wrinkles and folds, stimulation of natural collagen production, and the lasting results that patients and physicians expect from Radiesse, as well as providing patients significant reduction in pain due to the addition of lidocaine.
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The FDA has approved the ResQCPR System, a system of two devices for first responders to use while performing cardiopulmonary resuscitation on people whose hearts stop beating (cardiac arrest). The devices may improve the patient’s chances of surviving cardiac arrest.
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United Therapeutics Corporation announced that the FDA has approved Unituxin (dinutuximab) Injection (formerly called ch14.18), in combination with granulocyte-macrophage colony-stimulating factor, interleukin-2, and 13-cis-retinoic acid, for the treatment of pediatric patients with high-risk neuroblastoma who achieve at least a partial response to prior first-line multiagent, multimodality therapy. Unituxin is a chimeric biologic antibody that induces cell lysis of GD2-expressing cells through antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity and is part of an immunotherapeutic regimen to treat pediatric high-risk neuroblastoma.
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Sandoz announced that the FDA approved Zarxio (filgrastim-sndz) for all indications included in the reference product's label. Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar to the US-licensed reference product. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee.
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FDA New Indications
The FDA has expanded the approved use of the CoreValve System to treat certain patients who have previously had a tissue aortic valve replacement and are in need of a second one. The FDA previously approved the CoreValve System to treat patients whose own aortic valve has become severely narrowed as a result of calcium buildup around the heart valve (aortic stenosis) and who are considered to be at “extreme risk” or “high risk” for surgical aortic valve replacement.
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The FDA has expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema. The FDA previously approved Eylea to treat wet (neovascular) age-related macular degeneration. Eylea is also approved to treat DME and macular edema secondary to retinal vein occlusions, both of which cause fluid to leak into the macula resulting in blurred vision.
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Vertex Pharmaceuticals Incorporated has announced that the FDA approved Kalydeco for use in children ages 2 to 5 with cystic fibrosis who have 1 of 10 mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene (G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, and R117H). Prior to today's approval, Kalydeco was approved in the US for people ages 6 and older with these mutations.
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Actavis has announced that the FDA has approved its supplemental new drug application for Saphris (asenapine) as monotherapy for the acute treatment of manic or mixed episodes associated with bipolar I disorder in pediatric patients (ages 10–17). Saphris will be available for pediatric patients with bipolar I disorder in 2.5mg, 5mg, and 10mg black cherry flavor sublingual tablets in Q2 2015.
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FDA New Formulations
Actavis announced the FDA has approved a lower therapeutic dose of Viibryd (vilazodone HCl) (20mg) to accompany the 40mg daily therapeutic dose. This supplemental new drug application approval for Viibryd expands dosing options available to healthcare providers when using Viibryd to treat their adult patients with major depressive disorder. The Viibryd 20mg therapeutic dose is now available in pharmacies.
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Lactated Ringer's Irrigation
Hospira, Inc. announced it is initiating a voluntary recall of one lot of Lactated Ringer's Irrigation, 3000mL (NDC 0409-7828-08, Lot 40-008-JT; Expiry 1APR2016) to the user level (both human and veterinary) due to a confirmed customer report of several dark, fibrous particulates floating within the solution of the primary container. The particulate was confirmed as a common non-toxic, non-invasive mold, Aspergillus kanagawaensis. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.
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Magnesium Sulfate in 5% Dextrose Injection
Hospira announced a voluntary recall of one lot of Magnesium Sulfate in 5% Dextrose, Injection, USP, 10mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry 1DEC2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for Heparin Sodium 2000 USP units/1000mL in 0.9% Sodium Chloride Injection.
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North Carolina Board of Pharmacy Recall
The North Carolina Board of Pharmacy has ordered a recall for all lots of non-sterile and sterile products compounded, repackaged, and distributed by Prescription Center Pharmacy located at 915 Hay Street, Fayetteville, NC, between September 10, 2014, and March 10, 2015. This recall order is due the pharmacy’s inability to ensure sterility, stability, and potency for these products. In addition to ordering a recall, the Board of Pharmacy ordered the Prescription Center closed.
Learn more about the North Carolina Board of Pharmacy Recall
Plum A+ and Plum A+3 Infusion Systems
The Plum A+ and A+3 infusion pumps have an alarm that should sound when a therapy is interrupted. Some of the alarms may fail to sound in situations that should trigger it. It is possible for a long delay before a healthcare professional becomes aware of the need to restore therapy. For patients receiving critical intravenous medication, there is a risk of injury or death resulting from this prolonged interruption in therapy. Manufacturing and distribution dates are from July 2012 to May 2014. Date recall initiated: May 28, 2014.
Learn more about the Plum A+ and Plum A+3 Infusion Systems
UltraZx, Labs, L.L.C. is voluntarily recalling UltraZx weight loss supplements. This product has been found to contain undeclared sibutramine and phenolphthalein. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. Phenolphthalein is a chemical that is not an active ingredient in any approved drug in the US. Studies have indicated that it presents a cancer-causing risk. This product may also interact, in life-threating ways, with other medications a consumer may be taking.
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The FDA has issued a final guidance to assist industry in developing opioid drug products with potentially abuse-deterrent properties. Opioid drugs provide significant benefit for patients when used properly; however, opioids also carry a risk of misuse, abuse, and death. To combat opioid misuse and abuse, the FDA is encouraging manufacturers to develop abuse-deterrent drugs that work correctly when taken as prescribed, but, for example, may be formulated in such a way that deters misuse and abuse, including making it difficult to snort or inject the drug for a more intense high. While drugs with abuse-deterrent properties are not “abuse-proof,” the FDA sees this guidance as an important step toward balancing appropriate access to opioids for patients with pain with the importance of reducing opioid misuse and abuse.
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The FDA is warning that the prescription smoking cessation medicine Chantix (varenicline) can change the way people react to alcohol. Interactions between alcohol and Chantix have resulted in some patients experiencing increased intoxicating effects of alcohol, sometimes associated with aggressive behavior and/or amnesia. In addition, rare accounts of seizures in patients treated with Chantix have been reported. The FDA has approved changes to the Chantix label to warn about these risks.
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Duodenoscope Model TJF-Q180V
Olympus has issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling. The FDA has reviewed these new reprocessing instructions and the validation data as part of its ongoing review of the 510(k), and recommends that any facilities that are using Olympus’ TJF-Q180V duodenoscope train staff on the new instructions and implement them as soon as possible.
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The FDA is strengthening an existing warning that serious, potentially fatal allergic reactions can occur with the anemia drug Feraheme (ferumoxytol). The FDA changed the prescribing instructions and approved a Boxed Warning, the FDA’s strongest type of warning, regarding these serious risks. Also added is a new Contraindication, a strong recommendation against use of Feraheme in patients who have had an allergic reaction to any intravenous iron replacement product.
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Hepatitis C Treatments Containing Sofosbuvir
The FDA is warning that serious slowing of the heart rate can occur when the antiarrhythmic drug amiodarone is taken together with either the hepatitis C drug Harvoni (ledipasvir/sofosbuvir) or with Sovaldi (sofosbuvir) taken in combination with another direct-acting antiviral for the treatment of hepatitis C infection. The FDA is adding information about serious slowing of the heart rate, known as symptomatic bradycardia, to the Harvoni and Sovaldi labels. The FDA is recommending that healthcare professionals should not prescribe either Harvoni or Sovaldi combined with another direct-acting antiviral, such as the investigational drug daclatasvir or Olysio (simeprevir), with amiodarone.
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Mammograms at Richard D. Adelman M.D., Family Medicine
The FDA is alerting patients who had mammograms at Richard D. Adelman, M.D., Family Medicine practice located in Raleigh, North Carolina, any time after August 24, 2012, about possible problems with the quality of their mammograms. The American College of Radiology (ACR) did a review of mammograms performed by the Richard D. Adelman, M.D., Family Medicine practice between August 25, 2012, and August 25, 2014 and identified problems with the quality of the mammograms. ACR revoked the facility's accreditation on November 5, 2014. On November 18, 2014, the FDA required the facility to notify all patients who received mammograms at its facility any time after August 24, 2012 about these problems, and to stop performing mammography.
Learn more about Mammograms at Richard D. Adelman M.D., Family Medicine
Over-the-Counter Asthma Products Labeled as Homeopathic
The FDA is warning consumers not to rely on asthma products labeled as homeopathic that are sold over-the-counter. These products have not been evaluated by the FDA for safety and effectiveness.
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Prescription Center Pharmacy
The FDA is joining the North Carolina Board of Pharmacy (NC BOP) to urge healthcare professionals, including veterinarians, and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina. In an inspection conducted in March by the NC BOP, state inspectors observed significant deficiencies that raise concerns about the company’s ability to assure the sterility, stability, and potency of the sterile and non-sterile human and veterinary drug products that it produced. The Prescription Center has been closed by order of the NC BOP, and the NC BOP has ordered a recall of all lots of sterile and non-sterile products compounded or repackaged and distributed by the Prescription Center between September 10, 2014, and March 10, 2015.
Learn more about the Prescription Center Pharmacy
The FDA is warning healthcare professionals not to use Treanda Injection (45mg/0.5mL or 180mg/2mL solution) with closed system transfer devices (CSTDs), adapters, and syringes containing polycarbonate or acrylonitrile-butadiene-styrene (ABS). Most marketed CSTDs contain either polycarbonate or ABS and are not compatible with Treanda Injection (45mg/0.5mL or 180mg/2mL solution).
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The FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug Zyprexa Relprevv (olanzapine pamoate) in 2 patients who died. The study results were inconclusive. The FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the 2 patients who died 3 to 4 days after receiving injections of appropriate doses of Zyprexa Relprevv. On the basis of all of the information reviewed, the FDA is not recommending any changes to the current prescribing or use of Zyprexa Relprevv injection at this time. Patients should not stop receiving treatment without first talking to their healthcare professionals.
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