FDA New Approvals
Acuity X4 Quadripolar Left Ventricular (LV) Leads
Boston Scientific has received FDA approval for the Acuity X4 Quadripolar LV leads. The family of Acuity X4 Quadripolar LV leads is engineered with four electrodes along a unique 3D shape. The leads are designed to enable physicians to place them in the vasculature easily and to allow pacing at an optimal site to improve the patient response to CRT therapy.
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UCB announced that the FDA has approved Briviact (brivaracetam) as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy. Briviact will be available in three formulations (film-coated tablets, oral solution, and injection).
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CSL Behring announced that the FDA has approved Idelvion (coagulation factor ix [recombinant], albumin fusion protein), a long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for the treatment of hemophilia B.
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Gilead Sciences, Inc. announced that the FDA has approved Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg or R/F/TAF) for the treatment of HIV-1 infection in certain patients. Odefsey is indicated as a complete regimen for the treatment of HIV-1 infection in patients 12 years of age and older who have no antiretroviral treatment history and HIV-1 RNA levels less than or equal to 100,000 copies per mL. Odefsey is also indicated as replacement for a stable antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Odefsey.
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FDA New Formulations
Pfizer Inc. announced that the FDA has approved
Xeljanz XR (tofacitinib citrate) extended-release 11mg tablets for the
once-daily treatment of moderate to severe rheumatoid arthritis in patients who
have had an inadequate response or intolerance to methotrexate.
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FDA New Indications
Novartis announced that the FDA approved Afinitor (everolimus) tablets for the treatment of adult patients with progressive, well-differentiated, nonfunctional neuroendocrine tumors of gastrointestinal or lung origin that are unresectable, locally advanced, or metastatic.
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Genentech announced that the FDA approved Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. With this approval, Gazyva is approved in the United States to treat two common types of blood cancer. Gazyva is also approved in combination with chlorambucil for people with previously untreated chronic lymphocytic leukemia.
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Gilead Sciences, Inc. announced that the FDA has approved additional indications for Harvoni (ledipasvir/sofosbuvir) for use in chronic hepatitis C patients with advanced liver disease. Harvoni in combination with ribavirin for 12 weeks was approved for use in chronic hepatitis C virus (HCV) genotype 1- or 4-infected liver transplant recipients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and for HCV genotype 1-infected patients with decompensated cirrhosis (Child-Pugh B or C), including those who have undergone liver transplantation. Harvoni is now approved for use in a broader range of patient populations, including HCV genotypes 1, 4, 5, and 6, HCV/HIV-1 coinfection, HCV genotype 1 and 4 liver transplant recipients, and genotype 1-infected patients with decompensated cirrhosis.
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Pfizer Inc. announced that the FDA has approved a new indication expanding the use of Ibrance (palbociclib) 125mg capsules, Pfizer’s metastatic breast cancer therapy. Now Ibrance also is approved for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.
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AbbVie announced the FDA approved Imbruvica (ibrutinib) as a first-line treatment for patients with chronic lymphocytic leukemia (CLL). Imbruvica is approved to treat patients with CLL, patients with mantle cell lymphoma who have received at least one prior therapy, and patients with Waldenström's macroglobulinemia.
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FDA New Dosage Strength
Aczone Gel, 7.5%
Allergan announced that the company has received approval from the FDA to market Aczone (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older. Aczone Gel, 7.5% will be available in May 2016 nationwide.
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0.9% Sodium Chloride Solution for Irrigation
Baxter International is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500mL Plastic Pour Bottle solution—Lot G120162, expiration 11/30/2018—to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect. The lot being recalled was distributed to customers and distributors in the United States between November 12, 2015 and January 11, 2016.
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Beacon Tip Angiographic Catheters
Cook Medical has expanded its original July 2015 recall for the Beacon Tip Catheter to include additional product lots. The recall now affects 408,011 total catheters distributed in the US. Cook Medical started the original recall after it received complaints that the catheter tip may split or separate, and could potentially enter the patient’s bloodstream. This could cause serious injury to the patient and require additional medical intervention to retrieve the tip, or cause death. Tip splitting or separation may also cause the device to stop working.
Learn more about Beacon Tip Angiographic Catheters
Central Venous Catheters and Pressure Monitoring Sets and Trays
During an internal inspection by Cook Medical, a catheter exhibited the potential for catheter tip fracture and/or separation. Further investigation revealed that the technique used by the product assembler while tipping the catheter likely contributed to this nonconformance. Potential adverse events that may occur as a result of catheter tip fracture and/or separation include loss of device function, the need for medical intervention to retrieve a separated segment, and complications resulting from a separated tip occluding blood flow to end organs. The Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays in this recall were distributed globally between April 24, 2015 and October 23, 2015.
Learn more about Central Venous Catheters and Pressure Monitoring Sets and Trays
Morphine Sulfate 0.5mg/mL Preservative Free in 0.9% Sodium Chloride
The FDA is alerting healthcare professionals of a voluntary recall of morphine sulfate 0.5mg/mL preservative free in 0.9% sodium chloride, 1mL syringe, CII, for intravenous use made and distributed by Pharmakon Pharmaceuticals, because the product is super-potent. Injecting a patient with super-potent morphine could result in serious consequences including respiratory depression, coma, and death. The recalled product was made on February 3, 2016, with an expiration date of March 19, 2016, and labeled with lot E52418EV11C and NDC 45183-0322-78. The recalled product was distributed to two medical facilities—one in Indiana and one in Illinois.
Learn more about Morphine Sulfate 0.5mg/mL Preservative Free in 0.9% Sodium Chloride
Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators
Dräger is recalling the Oxylog Emergency Transport Ventilators because an electrical issue may cause the device to stop working if the control knobs (adjustment potentiometers) are not regularly used. If the device operator does not intervene, the patient may not receive enough oxygen and could suffer serious adverse health consequences, including injury or death.
Learn more about Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators
Syrspend SF and Syrspend SF Grape Suspending Agents
The FDA is alerting compounding pharmacies of the voluntary recall of
certain lots of SyrSpend SF and SyrSpend SF Grape suspending agents used in
compounding of various oral liquid drug products, due to the presence of yeast
Learn more about Syrspend SF and Syrspend SF Grape Suspending Agents
ED-3490TK Video Duodenoscope
Pentax has issued updated, validated manual reprocessing instructions for the ED-3490TK Video Duodenoscope to replace those provided in the original device labeling. The FDA reviewed these updated reprocessing instructions and the validation data and recommends that facilities using Pentax ED-3490TK Video Duodenoscopes train staff on the updated instructions and implement them as soon as possible.
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The FDA is revising its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics regarding its November 2015 Recall Order. Because Custom Ultrasonics has not demonstrated that its Automated Endoscope Reprocessors (AERs) can adequately wash and disinfect endoscopes to mitigate the risk of patient infection, the Agency continues to recommend that healthcare facilities using Custom Ultrasonics AERs transition to alternative methods to reprocess flexible endoscopes as soon as possible, as emphasized in its previous Communication. AERs are free-standing units used in healthcare facilities to disinfect flexible endoscopes and scope accessories between uses. Custom Ultrasonics AERs are intended to wash and high-level disinfect cleaned flexible endoscopes used in gastrointestinal and pulmonary tracts.
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The FDA announced actions to provide important information about the risks of using Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. The FDA issued a new, mandatory clinical study for Essure to determine heightened risks for particular women. The FDA also intends to require changes to product labeling, including a boxed warning and a Patient Decision Checklist to help to ensure women receive and understand information regarding the benefits and risks of this type of device. The FDA has issued a draft guidance to provide the public an opportunity to comment on the proposed language to be included in these warnings.
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Evita V500 and Babylog VN500 Ventilators
Dräger Medical expanded its December 2015 recall to include the PS500 Optional Power Supply units that were updated with new software as part of the December recall. The new software installed failed to correct the issue depleting the battery and Dräger Medical will now replace all affected PS500 power supply units. The ongoing PS500 power supply issue could cause the ventilator to shut down unexpectedly. If the ventilator shuts down, a patient may not receive necessary oxygen. This could cause patient injury or death.
Learn more about Evita V500 and Babylog VN500 Ventilators
Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg/100mL
Sagent has initiated a voluntary recall of one lot of Fluconazole Injection, USP, 200mg per 100mL to the user level due to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval. This impurity has been identified as metronidazole. An elevated impurity has the potential to decrease effectiveness of the product in patients. Patients on the product and on concomitant medication of metronidazole may receive an increased dose of metronidazole.
Learn more about Fluconazole Injection, USP, (in 0.9% Sodium Chloride) 200mg/100mL
MitraClip Delivery System
Abbott initiated a voluntary safety notice regarding the MitraClip Delivery System to reinforce the proper procedures used to operate and deploy the device. The company received a small number of reports involving MitraClip Delivery Systems where the user was unable to separate the implantable Clip from the delivery system.
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Neurosurgical Head Holders (Skull Clamps)
From January 2009 to January 2016, the FDA received more than 1,000 medical device reports associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries. These reports describe unintended patient movement during surgical procedures that resulted in injuries including skull fractures, facial injuries (bruises and cuts), deep cuts (lacerations), and blood clots (hematoma). Additionally, unintended patient movement has compromised procedures dependent upon head immobilization, causing inaccurate stereotaxic navigation and delayed, prolonged, or halted surgical procedures. Based on current information, the FDA believes the overall benefits of these devices continue to outweigh the risks. However, healthcare providers should be aware of patient-specific characteristics, techniques for safe use, and maintenance of neurosurgical head holder systems to prevent skull clamps from slipping before and/or during surgical procedures.
Learn more about Neurosurgical Head Holders (Skull Clamps)