FDA New Approvals
Alere i Diagnostic Test
The Alere i Influenza A & B 2 rapid molecular diagnostic test for use in children and adults has been cleared by the FDA for marketing. According to Alere, this is a second-generation rapid molecular assay, which delivers lab-accurate results in less time, with the ability to report a positive result in as little as 5 minutes. The test will be available for use in hospitals in time for the 2017-2018 respiratory season.
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The FDA granted accelerated approval to Aliqopa (copanlisib) for the treatment of adults with relapsed follicular lymphoma who have received at least two prior treatments known as systemic therapies. Follicular lymphoma is a slow-growing type of non-Hodgkin lymphoma, a cancer of the lymph system. Aliqopa is a kinase inhibitor that works by blocking several enzymes that promote cell growth.
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Cobas Zika Test
The FDA approved the cobas Zika test, a qualitative nucleic acid test for the detection of Zika virus RNA in individual plasma specimens obtained from volunteer donors of whole blood and blood components, and from living organ donors. It is intended for use by blood collection establishments to detect Zika virus in blood donations, not for the individual diagnosis of Zika virus infection.
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FreeStyle Libre Flash Glucose Monitoring System
The FDA approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions without calibration using a blood sample from the fingertip (often referred to as a “fingerstick”).
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The FDA cleared the first seven tesla (7T) magnetic resonance imaging (MRI) device, more than doubling the static magnetic field strength available for use in the U.S. The Magnetom Terra is the first 7T MRI system cleared for clinical use in the U.S. The Magnetom Terra is for patients who weigh more than 66 pounds and is limited to examinations of the head, arms and legs (extremities).
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The FDA approved Mvasi (bevacizumab-awwb) as a biosimilar to Avastin (bevacizumab) for the treatment of multiple types of cancer. Mvasi is the first biosimilar approved in the U.S. for the treatment of cancer. Mvasi is approved for the treatment of adult patients with certain colorectal, lung, brain, kidney and cervical cancers. Like Avastin, the labeling for Mvasi contains a Boxed Warning to alert healthcare professionals and patients about an increased risk of holes in the stomach and intestines (gastrointestinal perforations); surgery and wound healing complications; and severe or fatal pulmonary, gastrointestinal, central nervous system and vaginal bleeding (hemorrhage).
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Pentax ED34-i10T Duodenoscope
The FDA cleared the first duodenoscope with a disposable distal cap, a new feature that will improve access for cleaning and reprocessing. The Pentax ED34-i10T model duodenoscope is intended to provide visualization and access to the upper gastrointestinal (GI) tract to treat bile duct disorders and other upper GI problems. The new features of the Pentax ED34-i10T include a single-use detachable and disposable distal cap, simpler user interface, improved ergonomics, improved image quality and a reduced length.
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Reset Device for Substance Use Disorders
The FDA permitted marketing of the first mobile medical application to help treat substance use disorders (SUDs). The Reset application is intended to be used with outpatient therapy to treat alcohol, cocaine, marijuana and stimulant SUDs. The application is not intended to be used to treat opioid dependence. The Reset device is a mobile medical application system containing a patient application and clinician dashboard. The device delivers cognitive behavioral therapy to patients to teach the user skills that aid in the treatment of SUDs and are intended to increase abstinence from substance abuse and increase retention in outpatient therapy programs. The system is intended to be used in conjunction with outpatient therapy and in addition to a contingency management system, a widely-used program for treating SUDs that uses a series of incentives to reward patients for adherence to their treatment program.
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The FDA cleared the Senhance System, a new robotically-assisted surgical device that can help facilitate minimally invasive surgery. The design of the Senhance System allows surgeons to sit at a console unit or cockpit that provides a 3D high-definition view of the surgical field and allows them to control three separate robotic arms remotely. The end of each arm is equipped with surgical instruments that are based on traditional laparoscopic instrument designs. The system also includes unique technological characteristics: force feedback, which helps the surgeon “feel” the stiffness of tissue being grasped by the robotic arm; eye-tracking, which helps control movement of the surgical tools and laparoscopic-type controls similar to traditional surgical equipment.
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The FDA approved an antibiotic Solosec (secnidazole) for women with bacterial vaginosis. Solosec is the first single-dose oral treatment for bacterial vaginosis, the most common vaginal infection in women aged 15 to 44 years, according to the CDC. A dose of Solosec comes in the form of a 2g packet of granules. Patients sprinkle the granules on applesauce, yogurt or pudding and eat the mixture within 30 minutes without chewing or crunching the granules.
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The FDA approved Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), a once-daily, single inhaler triple therapy fluticasone for patients with chronic obstructive pulmonary disease. It is not indicated for acute bronchospasm or asthma. The combination inhaler contains 10 µg fluticasone, an inhaled corticosteroid; 62.5 µg umeclidinium, a long-acting muscarinic antagonist; and 25 µg vilanterol, a long-acting β2-adrenergic agonist.
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The FDA approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer that has progressed after taking therapy that alters a patient’s hormones (endocrine therapy). Verzenio is approved to be given in combination with an endocrine therapy, fulvestrant, after the cancer had grown on endocrine therapy. It is also approved to be given on its own if patients were previously treated with endocrine therapy and chemotherapy after the cancer had metastasized.
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The FDA has approved Zilretta (triamcinolone acetonide extended-release injectable suspension), the first and only extended-release, intra-articular injection for osteoarthritis knee pain. Zilretta uses proprietary microsphere technology combining triamcinolone acetonide (a commonly administered, short-acting corticosteroid) with a poly lactic-co-glycolic acid matrix to provide extended pain relief over 12 weeks. Flexion expects Zilretta will be available in the U.S. by the end of October.
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FDA First-Time Generic Approvals
Glatiramer Acetate Injection, 40mg/mL
This new generic for Copaxone is indicated for the treatment of the frequency of relapses in certain patients with relapsing-remitting multiple sclerosis.
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Oseltamivir Phosphate for Oral Suspension 6mg(base)/mL
The FDA has approved the first generic version of Tamiflu for oral suspension 6mg(base)/mL. Tamiflu is a medication for the treatment of influenza A and B. Generic oseltamivir phosphate for oral suspension comes in three doses, 30mg, 45mg, and 75mg, and is indicated for patients aged 2 weeks and older who have had flu symptoms for no more than 48 hours. It is also indicated for the prevention of influenza in patients aged 1 year and older.
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FDA Labeling Updates
The FDA approved a safety label change for Revlimid (lenalidomide) that includes an update to warning and precautions regarding severe cutaneous reactions, including hypersensitivity reactions. Angioedema and severe cutaneous reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported from Revlimid. DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis and/or pericarditis. These events can be fatal. Revlimid must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN or DRESS is suspected and should not be resumed following discontinuation for these reactions.
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The FDA approved several safety label changes for Tracleer (bosentan). Initiation of Tracleer in patients with elevated aminotransferases (>3X ULN) prior to drug initiation should be avoided because monitoring hepatotoxicity in these patients may be more difficult. In WHO Functional Class II patients, consideration should be given to if the benefits of Tracleer are sufficient to offset the risk of hepatotoxicity. Based on data from animal reproduction studies, Tracleer may cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. Tracleer is only available for females through a restricted program under a REMS. Females of reproductive potential should be advised of the potential risk to a fetus and not to breastfeed during treatment. Women should obtain a pregnancy test prior to treatment, monthly during treatment and for one month after stopping treatment. Females of reproductive potential should use two reliable forms of contraception during treatment with Tracleer and for at least one month after the last dose. Decreased sperm counts have been observed in patients receiving Tracleer, which may impair fertility, and it is unknown whether effects on fertility would be reversible.
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FDA New Indications
The FDA approved Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in patients 4 years of age and older based on extrapolation of adult data. This pathway to support a pediatric indication is based on extrapolating adult efficacy for treatment of partial onset-seizures to pediatric patients age 4 years and older in an adjunctive treatment scenario. This approach allowed determination of a dosing regimen that would provide similar exposures (at levels demonstrated to be effective in adults) in pediatric subjects age 4 years and older to eslicarbazepine exposure in adult subjects with partial-onset seizures.
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The FDA has approved Botox Cosmetic (onabotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe forehead lines associated with frontalis muscle activity in adults. It marks the third indication for Botox Cosmetic for injection, which is already FDA approved to address moderate to severe lateral canthal lines (crow’s feet) and moderate to severe glabellar lines (frown lines) in adults.
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The FDA has approved Briviact (brivaracetam) as monotherapy for partial-onset (focal) seizures in children with epilepsy aged 16 years and older. In 2016 the FDA approved Briviact as adjunctive therapy for partial-onset seizures in patients aged 16 years and older with epilepsy. Brivaracetam, a selective, high-affinity synaptic vesicle protein 2A ligand, is available in film-coated tablets, oral solution, and injection.
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Baxter Intralipid 20% IV Fat Emulsion
Baxter International Inc. announced it is voluntarily recalling one shipment from a single lot of Intralipid 20% IV Fat Emulsion, 100mL, distributed between 8/11/17 and 8/31/17 to hospitals and healthcare providers in the U.S., to the user level. The product has been exposed to subfreezing temperatures during transit to a distribution facility. The subfreezing temperature is outside of the acceptable storage range listed on the product labeling. Other shipments of this lot are not affected by this issue. If accidentally frozen, Intralipid 20% IV Fat Emulsion should not be used. When subjected to freezing, the emulsion droplets will increase in size, forming aggregates that can block pulmonary circulation and lead to serious adverse health consequences that can be life threatening.
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Gadget Island, Inc. (dba Gear Isle) Rhino Dietary Supplements
Gadget Island, Inc. is voluntarily recalling Rhino 7 Platinum 5000 capsules, all lots; Papa Zen 3300 capsules, LOT# NSS050888; Fifty Shades 6000 capsules, all lots; and Grande X 5800 capsules, all lots, to the consumer level. FDA analysis has found the products to be tainted with sildenafil and tadalafil, which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction, as well as desmethyl carbodenafil which is structurally similar to sildenafil.
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Genentech Activase 100mg vials
Genentech is voluntarily recalling three lots of Activase (alteplase) 100mg vials, that were co-packaged with sterile water for injection, to the hospital level. The vials of sterile water for injection, manufactured by Hospira Inc., a Pfizer company, and packaged with Activase 100mg, may be cracked or chipped at the neck of the vial and leaking.
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Kiriko, LLC A1 Slim Capsules
Kiriko, LLC is voluntarily recalling all lots of A1 Slim 30 capsules bottle to the consumer level. FDA laboratory analysis has found the A1 Slim product to be tainted with sibutramine, phenolphthalein and N-desmethyl sibutramine. These undeclared ingredients make this product an unapproved new drug for which safety and efficacy have not been established, and therefore, subject to recall.
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Medtronic Diabetes Infusion Sets
Medtronic is informing patients worldwide of a voluntary recall of specific lots of infusion sets used with all models of Medtronic insulin pumps. The recall is related to a certain discontinued component in these infusion sets and does not include insulin pumps or glucose sensors. The company determined, through recent field reports from patients and root cause analysis, that a component, the vent membrane, in the recalled infusion sets may be susceptible to being blocked by fluid during the process of priming/fill-tubing. This situation can lead to potential over-delivery of insulin shortly after an infusion set change, which may cause hypoglycemia.
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Nature Supplement Inc. Vegetable Vigra Capsule
Natures Supplement, Inc. is voluntarily recalling 260 bottles of Vegetable Vigra 200mg capsules to the consumer level. FDA analysis found this product to be tainted with sildenafil.
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OriGen Biomedical VV28F Reinforced Dual Lumen ECMO Catheters
OriGen Biomedical voluntarily recalled OriGen VV28F reinforced dual lumen ECMO catheters Lot N18487 and N18487-1 after becoming aware of a reported adverse event. The OriGen reinforced dual lumen ECMO catheter is indicated for use as a single cannula for both venous drainage and arterial re-infusion of blood in the internal jugular vein during extracorporeal life support procedures of six hours or less (U.S.) or less than 29 days (rest of world). Customers who have received product from either of these lots of VV28F reinforced dual lumen ECMO catheters should return any product that they currently have to OriGen Biomedical.
Learn more about the OriGen Biomedical VV28F reinforced dual lumen ECMO catheter recall
Spectranetics Corp. Bridge Occlusion Balloon Catheter Model 590-001
Spectranetics is performing a Class I Recall of its Bridge Occlusion Balloon Catheter due to the possibility of a blocked guidewire lumen in some device units. If a device with a blocked guidewire lumen were to be used during the procedure, the device would not be positioned correctly and hemorrhage would not be controlled. This would delay life-saving treatment, which may result in immediate and serious adverse health consequences, including death. Lot numbers include FMN17B13A, FMN17C08A, FMN17C28A, FMN17D07A, FMN17D12A, FMN17D19A, FMN17D27A, FMN17E02A, FMN17E23A, FMN17E31A, FMN17E31B, FMN17F06A, FMN17F20A, FMN17F21A, FMN17G12A, FMN17G18A, FMN17H03A, FMN17H03A, FMN17H03A, FMN17H10A, FMN17H29A.
Learn more about the Spectranetics Corp. Bridge Occlusion Balloon Catheter model 590-001 recall
Boston Scientific Urogynecologic Surgical Mesh Implants
The FDA is aware of allegations that Boston Scientific's urogynecologic surgical mesh may contain counterfeit raw material. The FDA 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. The FDA is examining these allegations to determine any necessary and appropriate next steps.
Learn more about Boston Scientific urogynecologic surgical mesh implants
Imprimis Pharmaceuticals, Inc. Compounded Triamcinolone, Moxifloxacin and Vancomycin Intraocular Injection
The FDA received an adverse event report on August 14, 2017 from a physician concerning a patient who was diagnosed postoperatively with bilateral hemorrhagic occlusive retinal vasculitis (HORV) after being administered injections of a compounded triamcinolone, moxifloxacin and vancomycin (TMV) formulation in each eye at the conclusion of cataract surgery procedures that were done two weeks apart. HORV is a rare, potentially blinding postoperative complication that has been observed in dozens of patients who have received intraocular injections of vancomycin formulations toward the end of otherwise uncomplicated cataract surgeries. The TMV formulation was compounded by Imprimis Pharmaceuticals, Inc.
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Intercept Pharmaceuticals Ocaliva
The FDA is warning that the liver disease medicine Ocaliva (obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. These patients are receiving excessive dosing, particularly a higher frequency of dosing than is recommended in the drug label for them. Ocaliva may also be associated with liver injury in some patients with mild disease who are receiving the correct dose. The recommended dosing and monitoring for patients on Ocaliva are described in the current drug label. Ocaliva is used to treat a rare, chronic liver disease known as primary biliary cholangitis.
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Opioid Addiction Medications in Patients Taking Benzodiazepines or CNS Depressants
The FDA is advising that the opioid addiction medications buprenorphine and methadone should not be withheld from patients taking benzodiazepines or other drugs that depress the central nervous system. The combined use of these drugs increases the risk of serious side effects; however, the harm caused by untreated opioid addiction can outweigh these risks. Careful medication management by healthcare professionals can reduce these risks. We are requiring this information to be added to the buprenorphine and methadone drug labels along with detailed recommendations for minimizing the use of medication-assisted treatment drugs and benzodiazepines together.
Learn more about concurrent use of buprenorphine and methadone with central nervous system depressants
SynCardia Systems TAH-t Companion 2 Driver System (C2) and Freedom Driver System
The FDA issued an update to the October 2016 letter to healthcare providers, to inform the healthcare community of the most recent, interim results from the ongoing SynCardia TAH-t post-approval study that is looking at mortality and neurological adverse events. These interim results continue to reflect a higher three-month mortality rate for the subgroup of patients requiring pre-implant circulatory rescue interventions when using the C2 Driver System compared to those using the CSS Console. The mortality rates for patients who did not require pre-implant circulatory rescue interventions continued to be similar for the C2 Driver System compared to the CSS Console.
Learn more about the SynCardia Systems TAH-t C2 and Freedom Driver System