FDA New Approvals
Elusys Therapeutics, Inc. announced that the FDA has approved Anthim
(obiltoxaximab) Injection, the company’s monoclonal antibody anthrax antitoxin.
Anthim is indicated in adult and pediatric patients for the treatment of
inhalational anthrax due to Bacillus anthracis in combination with appropriate
antibacterial drugs, and for prophylaxis of inhalational anthrax when
alternative therapies are not available or are not appropriate.
Learn more about Anthim
Teva Pharmaceutical Industries Ltd. announced that the FDA has approved Cinqair (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody indicated for add-on maintenance treatment of patients aged 18 years and older with severe asthma, and with an eosinophilic phenotype. Cinqair is administered by intravenous infusion at a weight-based dose of 3mg/kg once every four weeks. The treatment is expected to become commercially available to patients, by prescription, during the second quarter of 2016.
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Jazz Pharmaceuticals announced that the FDA granted marketing approval for Defitelio (defibrotide sodium) for the treatment of adult and pediatric patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with renal or pulmonary dysfunction following hematopoietic stem-cell transplantation.
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Gilead Sciences, Inc. announced that the FDA has approved Descovy (emtricitabine 200mg/tenofovir alafenamide 25mg, F/TAF), a fixed-dose combination for the treatment of HIV. Descovy is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older.
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Spectrum Pharmaceuticals announced that the FDA has granted approval of Evomela (melphalan) for use in two indications: 1) use as a high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma (MM), and 2) for the palliative treatment of patients with MM for whom oral therapy is not appropriate. This is the first product to be FDA-approved for the high-dose conditioning indication in MM.
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The FDA approved Celltrion’s Inflectra (biosimilar infliximab) across all eligible indications of the reference product, Remicade (infliximab). Inflectra is a treatment indicated for reducing signs and symptoms in patients with rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and adult and pediatric Crohn’s disease.
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Micra Transcatheter Pacing System
Medtronic announced it has received FDA approval of the Medtronic Micra Transcatheter Pacing System (TPS). The Micra TPS is the first FDA-approved product with miniaturized pacing technology. It is cosmetically invisible and small enough to be delivered through a catheter and implanted directly into the heart, providing a safe alternative to conventional pacemakers without the complications associated with cardiac wires (leads).
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The FDA has permitted the marketing of PneumoLiner, the first tissue containment system for use with certain laparoscopic power morcellators to isolate uterine tissue that is not suspected to contain cancer. Although the device is an effective tissue containment system, the FDA is requiring the manufacturer to warn patients and healthcare providers that PneumoLiner has not been proven to reduce the risk of spreading cancer during these procedures.
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Eli Lilly and Company announced that the FDA has approved Taltz (ixekizumab) injection 80mg/mL for the treatment of moderate-to-severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy. Taltz will be available in the United States beginning in the second quarter of 2016.
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Sensimed AG is pleased to announce the marketing clearance of the Sensimed Triggerfish by the FDA. The Sensimed Triggerfish is a unique sensor-embedded contact lens based system that Sensimed developed with the aim to improve the management of glaucoma.
Learn more about Sensimed Triggerfish
FDA First-Time Generic Approvals
Generic for Voltaren Gel
Amneal Pharmaceuticals LLC announced the launch of its first-to-market generic equivalent of Voltaren Gel (diclofenac sodium topical gel) 1% in the United States. Amneal recently received final approval from the FDA for its Abbreviated New Drug Application for the product. Amneal’s diclofenac sodium topical gel 1% is available in a 100g tube and is now shipping through wholesalers, distributors, and directly to the trade.
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FDA New Indications
The FDA has approved Bayer's Kovaltry antihemophilic factor (recombinant), an unmodified, full-length factor VIII compound for the treatment of hemophilia A in children and adults. Kovaltry can be used two or three times per week in adolescents and adults, and two or three times per week or every other day in children.
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Pfizer Inc. announced that the FDA has approved a supplemental New Drug Application for Xalkori (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. Xalkori is also indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase positive as detected by an FDA-approved test.
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FDA New Dosage Strength
Antares Pharma, Inc. announced the approval by the FDA of three new dosage strengths of Otrexup (methotrexate) injection. The new dosage strengths of 12.5mg/0.4mL, 17.5mg/0.4mL, and 22.5mg/0.4 mL will complement the already approved and marketed strengths of 7.5mg/0.4mL, 10mg/0.4mL, 15mg/0.4mL, 20mg/0.4mL, and 25mg/0.4mL. New, interim dose-strength options will enable physicians to select more specific, optimal doses to help achieve patient treatment goals.
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5% Dextrose Injection USP in PAB Container
B. Braun Medical Inc. is recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be microbial growth. A compromise of container integrity has the potential for leakage of the solution, usually identified prior to the use of the product. Leaking containers allow contamination of the solution, which can and has led to microbial contamination. Intravenous administration of a non-sterile product can result in serious infections that may be life-threatening.
Learn more about 5% Dextrose Injection USP in PAB Container
Amikacin Sulfate Injection USP, 1g/4mL (250mg/mL) Vials
Teva Pharmaceuticals announced a voluntary recall of one lot of amikacin sulfate injection USP, 1g/4mL (250mg/mL) vials due to the potential presence of particulate matter identified as glass in one vial. The recalled lot # is 4750915, Expiration Date 9/2017.
Learn more about Amikacin Sulfate Injection USP, 1g/4mL (250mg/mL) Vials
Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
Teleflex Incorporated announced a worldwide recall of Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits. Teleflex Incorporated initiated a worldwide recall of 47,140 units distributed to hospitals, clinics, and medical centers throughout the United States and globally. The Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits are being recalled because the sheath body may become separated from the sheath hub. If the separation occurs, the patient may bleed from the sheath. If bleeding is not promptly addressed, significant blood loss or exsanguination may occur. Interruption or loss of intra-aortic balloon pump treatment may also occur.
Learn more about Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits
Continuum Labs LGD-4033
Invisiblu International LLC is voluntarily recalling one lot of Continuum Labs LGD-Xtreme, 3mg to the retail and consumer level. The product has been found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown. The affected LGD-Xtreme lot numbers are 21511166 with expiration dates of 11/2018.
Learn more about Continuum Labs LGD-4033
GlideScope Titanium Single-Use Video Laryngoscope
Verathon Incorporated is recalling the GlideScope Titanium Single-Use Video Laryngoscope because of a potential disruption in the video feed from the camera in the laryngoscope blades to the monitor. A disrupted or unstable video image may lead to delayed tracheal tube insertion, intubation failure, and other serious adverse health consequences, including low levels of oxygen in the blood (hypoxemia), end organ damage or death.
Learn more about GlideScope Titanium Single-Use Video Laryngoscope
Human and Animal Compounded Products by Reliable Drug Pharmacy
Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico, and Michigan. The recall was issued after a series of onsite inspections by the FDA. This recall impacts all compounded products distributed between 09/24/2015 and 03/24/2016.
Learn more about Human and Animal Compounded Products by Reliable Drug Pharmacy
MitraClip Clip Delivery System
Abbott Vascular has recalled the MitraClip Clip Delivery System due to an issue with the delivery system deployment process. Abbott Vascular has received reports of cases where the Clip Delivery System could not be detached from the Clip due to a malfunction of the device. These cases resulted in open heart surgery to retrieve the delivery system. Abbott Vascular is therefore recalling the MitraClip Delivery System to provide updated instructions and training for healthcare providers who use the device. The use of affected products may cause serious adverse health consequences, including serious patient injury or death. Currently there are 3,534 devices on the market, with nine reports of this malfunction. There has been 1 death.
Learn more about MitraClip Clip Delivery System
NOW Health Group, Inc. Dietary Supplements
NOW Health Group, Inc. is voluntarily recalling limited quantities of six dietary supplements that are mislabeled due to a printing error from the label supplier. The recall affects approximately 165 total units that were distributed nationally and sold in retail stores and online.
Learn more about NOW Health Group, Inc. Dietary Supplements
Sodium Bicarbonate Injection, USP
Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint. The product is packaged 50mEq (1mEq/mL), 4.2g (84mg/mL), 50mL, Single-dose, packaged 4 boxes of 25 vials per case. The lot was distributed nationwide in the United States to wholesalers and hospitals in December 2015.
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The FDA issued a draft guidance intended to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADFs) while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug.
Learn more about Abuse-Deterrent Opioids
Best Bentonite Clay
The FDA is warning consumers not to use “Best Bentonite Clay,” a product of Best Bentonite, located in Guthrie, Oklahoma. The FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk. FDA laboratories have found elevated levels of lead in “Best Bentonite Clay.” Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.
Learn more about Best Bentonite Clay
Diabetes Medicines Containing Saxagliptin and Alogliptin
An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, The FDA is adding new warnings to the drug labels about this safety issue.
Learn more about Diabetes Medicines Containing Saxagliptin and Alogliptin
Duodenoscope Models TJF-160F and TJF-160VF
Olympus Corporation of the Americas has issued updated, validated manual reprocessing instructions for the TJF-160F and TJF-160VF duodenoscope models (160 F/VF duodenoscope models) to replace those provided in the original device labeling. The FDA reviewed the updated reprocessing instructions and the validation data and determined that they meet the Agency's expectations.
Learn more about Duodenoscope Models TJF-160F and TJF-160VF
Eye Drop Bottles
The FDA is warning the public about eye drop bottles that have loose plastic safety seals or tamper-evident rings below the bottle cap that may fall onto the eye when the product is used. The FDA has received reports of six adverse events associated with loose safety seals on eye drop bottles. The FDA is in the process of identifying all relevant products and will require a change in the packaging design.
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Human and Animal Sterile Drug Products
The FDA is alerting healthcare professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., due to lack of sterility assurance. The FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. Therefore, the FDA is alerting healthcare professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
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Interferences between Computed Tomography (CT) and Electronic Medical Devices
The FDA has received a small number of reports of adverse events that are believed to be associated with CT imaging of some implantable and wearable electronic devices (eg, insulin pumps, cardiac implantable electronic devices and neurostimulators). The FDA’s current understanding is that when a CT scanner directly irradiates the circuitry of certain implantable or wearable electronic medical devices (ie, when the device is visible in the resulting CT image), it can cause sufficient electronic interference to affect the function and operation of the medical device.
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The FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. The FDA was asked to review numerous medical studies regarding the safety of metformin use in patients with mild to moderate impairment in kidney function, and to change the measure of kidney function in the metformin drug labeling that is used to determine whether a patient can receive metformin.
Learn more about Metformin-containing Drugs
The FDA approved a supplemental application for Mifeprex based on data and information submitted by the drug manufacturer. After reviewing the supplemental application, the agency determined that Mifeprex is safe and effective when used to terminate a pregnancy in accordance with the revised labeling. Mifeprex is approved, in a regimen with misoprostol, to end a pregnancy through 70 days gestation (70 days or less since the first day of a woman’s last menstrual period).
Learn more about Mifeprex
Opioid Pain Medicines
The FDA is warning about several safety issues with the entire class of opioid pain medicines. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. The FDA is requiring changes to the labels of all opioid drugs to warn about these risks.
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OxySure Portable Emergency Oxygen System, Model 615
The FDA is recommending consumers, businesses, schools, and healthcare providers stop using OxySure Portable Emergency Oxygen System, Model 615 because of several device malfunctions, including ineffective oxygen delivery, and chemical reactions in the canisters that could cause them to explode. Due to adverse event reports to the FDA and the company’s failure to address the device’s safety issues noted during inspections and in the FDA’s warning letter, the FDA is concerned that patients and other users of OxySure Portable Emergency Oxygen System, Model 615 are at risk for serious adverse health consequences, such as burns and death. The FDA will continue to work with OxySure Therapeutics, Inc. to bring these devices into regulatory compliance and will keep the public informed if significant new information becomes available.
Learn more about OxySure Portable Emergency Oxygen System, Model 615
Powdered Medical Gloves
The FDA announced a proposal to ban most powdered gloves in the United States. While use of these gloves is decreasing, they pose an unreasonable and substantial risk of illness or injury to healthcare providers, patients, and other individuals who are exposed to them, which cannot be corrected through new or updated labeling. The proposed ban applies to powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove.
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Sterile Drug Products by Medaus Pharmacy
The FDA is alerting healthcare professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally.
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Urogynecologic Surgical Mesh Implants
The FDA is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material and is examining these allegations to determine any necessary and appropriate next steps. The FDA is not currently aware that the alleged counterfeit raw material contributes to adverse events associated with these products.
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The FDA is alerting healthcare professionals about reports of an increased rate of adverse events, including deaths, in clinical trials with the cancer medicine Zydelig (idelalisib) in combination with other cancer medicines. Gilead Sciences, Inc. has confirmed that they are stopping six clinical trials in patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and indolent non-Hodgkin lymphomas. The FDA is reviewing the findings of the clinical trials and will communicate new information as necessary.
Learn more about Zydelig