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The FDA has approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy, due to menopause. Intrarosa is the first FDA-approved product containing the active ingredient prasterone, which is also known as dehydroepiandrosterone (DHEA).
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The FDA has approved tenofovir alafenamide (Vemlidy, Gilead Sciences) 25mg once daily, for treatment of adults with chronic hepatitis B virus (HBV) infection with compensated liver disease. Gilead Sciences' tenofovir disoproxil fumarate (Viread) has potent antiviral activity in patients with chronic HBV infection, but long-term use has been associated with renal side effects and reduced bone mineral density in some patients.
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Novo Nordisk announced that the FDA approved the New Drug Application for Xultophy 100/3.6 (insulin degludec 100 units/mL and liraglutide 3.6mg/mL injection). Xultophy 100/3.6 is a once-daily, combination of Tresiba (insulin degludec injection) and Victoza (liraglutide) injection indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes inadequately controlled on less than 50 units of basal insulin daily or less than or equal to 1.8mg of liraglutide daily. Xultophy 100/3.6 enters into a new class of diabetes treatments that combine a basal insulin and a glucagon-like peptide-1 receptor agonist in a single, once-daily injection.
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Essure labeling now includes the addition of a boxed warning and a Patient Decision Checklist, both intended to support patient counseling and understanding of benefits and risks associated with Essure, as well as what to expect during and after the Essure procedure. The boxed warning includes safety statements to clearly communicate significant side effects or adverse outcomes associated with this device and information about the potential need for removal. The Patient Decision Checklist provides key information about the device, its use, and safety and effectiveness outcomes, of which the patient should be aware and discuss with her doctor as she considers her sterilization options. Bayer also incorporates important modifications to the patient counseling and device removal sections of the labeling to provide physicians with additional guidance in these critical areas.
Learn more about the Essure Permanent Birth Control System
The FDA approved daratumumab (Darzalex, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Daratumumab was previously granted accelerated approval in November 2015 as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent.
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Amgen announced that the FDA approved a supplemental biologics license application for use of Enbrel (etanercept) in children aged 4 years and older with chronic moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
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The FDA approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease. The FDA’s decision is based on a postmarketing study required by the agency when it approved Jardiance in 2014 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
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Cantrell Drug Company is voluntarily recalling certain unexpired sterile drug products due to lack of sterility assurance. Administration of a drug product intended to be sterile that is not sterile could result in serious infections that may be life-threatening. The recalled products were distributed nationwide to healthcare facilities from May 25 to October 31, 2016.
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NutriVitaShop, also doing business as Naturecom Inc., is requesting the nationwide recall of its DMAA net weight 500g because there may be presence of DMAA. Lot numbers include #20141102, 20150715, 20151022, 20160226, 20160701, 20161017, and 20150323. DMAA net weight 500g is packaged in approximately 8" x 11" silver and clear Mylar ziplock bags that contain 500g of DMAA. DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. The FDA has previously warned that DMAA is potentially dangerous to health as it can narrow blood vessels and arteries, which can cause a rise in blood pressure or other cardiovascular problems such as shortness of breath, arrhythmias, tightening in the chest, and heart attack.
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SentreHeart is recalling the FindrWIRZ Guidewire System because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients. Coating separation may be caused by issues with the device design or manufacturing processes. Lot Numbers 01160568, 02160586, 07160639 -150, distributed between June 1, 2016 and September 26, 2016 and manufactured between January 4, 2016 and July 22, 2016 are affected. Small pieces of the coating could break away and travel elsewhere in the body, or the exposed wire beneath the coating could cause dangerous blood clots in the patient’s bloodstream and can lead to serious adverse health consequences including embolism, stroke, or death.
Learn more about the FindrWIRZ Guidewire System
Medtronic is recalling certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters. They are issuing this recall due to the potential separation and detachment of the polytetrafluoroethylene (PTFE) coating on parts of these devices. PTFE coating is used to reduce friction between devices and ease navigation through the vasculature. If the PTFE separates from the device, it could enter the bloodstream of the patient. PTFE particles in the bloodstream may lead to downstream blood clots and/or irreversible brain injuries including ischemic stroke, thrombosis, and hemorrhage.
Learn more about Medtronic Neurovascular Products
MS Bionic, Inc. announced that it is conducting a voluntary nationwide recall of all lots of Megajex Natural Male Sex Enhancer capsules. FDA analysis has found the product to contain tadalafil and sildenafil. Tadalafil and sildenafil are FDA-approved drugs used as treatment for male erectile dysfunction. The active drug ingredients are not listed on the label for this product. To date, no adverse events have been reported. Megajex Natural Male Sex Enhancer is marketed as a dietary supplement for erectile dysfunction.
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Raritan Pharmaceuticals, a contract manufacturer for Homeolab USA, is voluntarily recalling homeopathic products containing belladonna extract, due to the potential for variation in the content of belladonna extract in the products. The FDA has tested some products and recovered varying levels of belladonna extract content from what is declared on the label.
Learn more about Raritan Pharmaceuticals products containing belladonna extract
Tri-Coast Pharmacy Inc. is voluntarily recalling all sterile products prepared between May 17, 2016 and November 17, 2016 and that remain within expiry, due to FDA concerns over the lack of sterility assurance of the drugs named in this recall. Administration of a drug product intended to be sterile that has microbial contamination has the potential to result in serious infections which may be life-threatening. No portion of any lot of these medications has been found to be non-sterile, but the FDA is concerned that the conditions under which they were produced introduce a lack of sterility assurance for these products.
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Ultimate Body Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules to the consumer level. FDA analyses of this product found it to contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in Ultimate Body Tox PRO renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. 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, irregular heartbeat, or stroke.
Learn more about Ultimate Body Tox PRO