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  • FDA Drug Updates

    FDA New Approvals

    Brineura

    The FDA approved Brineura (cerliponase alfa) as a treatment for a specific form of Batten disease. Brineura is the first FDA-approved treatment to slow loss of walking ability (ambulation) in symptomatic pediatric patients 3 years of age and older with late infantile neuronal ceroid lipofuscinosis type 2, also known as tripeptidyl peptidase-1 deficiency. Learn more about Brineura

    Imfinzi

    The FDA granted accelerated approval to Imfinzi (durvalumab) for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The FDA also approved the Ventana PD-L1 (SP263) Assay as a complementary diagnostic for the assessment of the PD-L1 protein in formalin-fixed, paraffin-embedded urothelial carcinoma tissue. Learn more about Imfinzi

    Kisqali Femara Co-Pack

    The FDA has approved the Kisqali Femara Co-Pack (ribociclib tablets; letrozole tablets) for the treatment of hormone receptor-positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer in postmenopausal women. The Kisqali Femara Co-Pack is the first, and only currently available, combination pack with two prescription products in advanced breast cancer. With this FDA approval, physicians in the U.S. now have the flexibility to prescribe Kisqali two different ways: via the new Co-Pack or as two separate prescriptions of Kisqali and any aromatase inhibitor. Learn more about the Kisqali Femara Co-Pack

    Philips IntelliSite Pathology Solution

    The FDA has permitted marketing of the Philips IntelliSite Pathology Solution (PIPS), as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The PIPS is an automated digital slide creation, viewing, and management system that will allow pathologists to review and interpret digital images of surgical pathology slides prepared from FFPE tissue, rather than having to look directly under a conventional light microscope at a tissue sample mounted on a glass slide. This is the first FDA-authorized digital pathology whole slide imaging system available for these purposes. Learn more about the PIPS

    Radicava

    The FDA approved Radicava (edaravone) to treat patients with amyotrophic lateral sclerosis, commonly referred to as Lou Gehrig’s disease. Radicava is an intravenous infusion given by a healthcare professional. It is administered with an initial treatment cycle of daily dosing for 14 days, followed by a 14-day drug-free period. Subsequent treatment cycles consist of dosing on 10 of 14 days, followed by 14 days drug-free. Learn more about Radicava

    Renflexis

    The FDA has approved Renflexis (infliximab-abda), a biosimilar referencing Remicade (infliximab), across all eligible indications. In the U.S., Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn's disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, and for the treatment of adult plaque psoriasis. Learn more about Renflexis

    RoxyBond

    The FDA has approved RoxyBond (oxycodone hydrochloride) tablets, for oral use, CII, indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. RoxyBond is an abuse-deterrent formulation of oxycodone that uses physical and chemical barriers to deter abuse, without the use of aversive agents or opioid antagonists. RoxyBond is the first immediate-release opioid analgesic approved with labeling describing its abuse-deterrent properties, consistent with the FDA's 2015 Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling. RoxyBond is approved in three dosage strengths: 5, 15, and 30mg. Learn more about RoxyBond

    Rydapt

    The FDA has approved Rydapt (midostaurin) for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who have a specific genetic mutation called FLT3, in combination with chemotherapy. The drug is approved for use with a companion diagnostic, the LeukoStrat CDx FLT3 Mutation Assay, which is used to detect the FLT3 mutation in patients with AML. Rydapt is a kinase inhibitor that works by blocking several enzymes that promote cell growth. If the FLT3 mutation is detected in blood or bone marrow samples using the LeukoStrat CDx FLT3 Mutation Assay, the patient may be eligible for treatment with Rydapt in combination with chemotherapy. Learn more about Rydapt

    FDA New Indications

    Bavencio

    The FDA granted accelerated approval to Bavencio (avelumab) for patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. The recommended dose of avelumab is 10mg/kg as an intravenous infusion over 60 minutes every 2 weeks. Premedicate with an antihistamine and acetaminophen prior to the first four infusions of avelumab. Learn more about Bavencio

    Stivarga

    The FDA expanded the approved use of Stivarga (regorafenib) to include treatment of patients with hepatocellular carcinoma (HCC or liver cancer) who have been previously treated with the drug sorafenib. This is the first FDA-approved treatment for a liver cancer in almost a decade. Stivarga is a kinase inhibitor that works by blocking several enzymes that promote cancer growth, including enzymes in the vascular endothelial growth factor pathway. Stivarga is also approved to treat colorectal cancer and gastrointestinal stromal tumors that are no longer responding to previous treatments. Learn more about Stivarga

    FDA Labeling Updates

    Saxenda

    The FDA approved an updated product label for Saxenda (liraglutide) injection 3mg, including data showing that approximately half of patients on Saxenda (26% vs 10% on placebo) who lost more than or equal to 5% of their weight after 56 weeks (56% vs 25% on placebo) maintained their weight loss for 3 years. Study participants were adults with obesity (body mass index [BMI] ≥30kg/m2) or excess weight (BMI ≥27kg/m2) with at least one weight-related comorbidity, on a reduced calorie meal plan and increased physical activity. The label update is based on data from the SCALE (Satiety and Clinical Adiposity - Liraglutide Evidence in adults with and without Diabetes) Obesity and Pre-diabetes 3-year trial that investigated the long-term efficacy and safety of Saxenda, in combination with a reduced-calorie meal plan and increased physical activity, in adults with pre-diabetes at screening. Learn more about Saxenda

    FDA Recalls

    25% Dextrose Injection, USP (Infant)

    Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as human hair, found within an internal sample syringe. In the event that the particulate is administered to a patient, it could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels, and/or systemic allergic response to the particulate. Administration of the particulate could also result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction. 25% Dextrose Injection, USP, (Infant) 2.5g (250mg/mL), 10mL Single-dose prefilled syringe, NDC:0409-1775-10, Lot 58382EV, Expiry Date 1OCT 2017 is packaged in a carton containing 1 pre-filled syringe per carton, 5 x 10 syringes per case. The lot was distributed from February 2016 through October 2016 nationwide in the U.S. and Puerto Rico. Learn more about 25% Dextrose Injection, USP (Infant)

    Amitriptyline HCl Tablets and Phenobarbital Tablets

    C.O. Truxton, Inc. is expanding their 04/21/2017 voluntary recall to include Amitriptyline HCl Tablets, USP 50mg and Phenobarbital Tablets, USP 15mg, 30mg, 60mg, 100mg as a precaution, due to potential label mix-up. C.O. Truxton has not received any complaints for the products listed; however, due to the initial recall resulting from a label mix-up error, out of an abundance of caution, they are recalling all products that were repackaged into a Truxton Incorporated label. C.O. Truxton, Inc. is notifying all customers on record who purchased the above-listed products under Truxton Incorporated label/NDC via US Mail with a recall letter and recall response form. C.O. Truxton, Inc. is arranging for full credit returns, replacements, etc. of all recalled product. Consumers/distributors/retailers that have recalled product should stop using the product immediately and return their product to the place of purchase. Learn more about Amitriptyline HCl Tablets and Phenobarbital Tablets

    GEC Laxoplex Dietary Supplement Capsules

    Genetic Edge Compounds recalled all lot codes of GEC Laxoplex dietary supplement capsules distributed between February 2, 2015 and May 2, 2017 to the retail level and consumer level. FDA analysis found GEC Laxoplex to be tainted with anabolic steroids and steroid-like substances. The presence of these anabolic steroids and steroid-like substances in GEC Laxoplex renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall. Use or consumption of products containing anabolic steroids may cause acute liver injury, which is known to be a possible harmful effect of using steroid-containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. Learn more about GEC Laxoplex dietary supplement capsules

    HVAD System Controllers and DC Adapters

    Medtronic plc announced that the FDA classified the company's recently initiated voluntary field action related to its HVAD System Controllers (serial numbers lower than CON300000) and DC Adapters (all serial numbers for product code 1435) as a Class I recall. Medtronic began notifying clinicians outside of the U.S. in March 2017 about updated HVAD System Controllers and DC Adapters that were developed following two previously communicated Field Safety Notices that occurred in April 2015 and April 2016. The FDA approved the updated controller on April 7, 2017, and Medtronic began notifying U.S. clinicians about the updated HVAD Controllers and DC Adapters on April 14, 2017. Learn more about HVAD System Controllers and DC Adapters

    Newport HT70 and Newport HT70 Plus Ventilators

    Newport Medical Instruments Inc., now a part of Medtronic, is recalling the Newport HT70 and Newport HT70 Plus ventilators because a software problem may cause the ventilator to shut down unexpectedly without sounding an alarm. If the ventilator shuts down, the patient may not receive enough oxygen and could suffer serious adverse health consequences such as brain damage, or even death. The Newport HT70 and HT70 Plus ventilators are intended to provide breathing support for individuals who require mechanical ventilation. These devices can be used with infant, pediatric, or adult patients greater than or equal to 5kg (11 lbs). These devices are used in hospitals, other healthcare facilities, and home care environments and may be used for transport and emergency response situations. Learn more about Newport HT70 and Newport HT70 Plus ventilators

    Phenobarbital 15mg Tablets

    C.O. Truxton, Inc. is voluntarily recalling lot 70952A of Phenobarbital Tablets, USP, 15mg, to the consumer/user level. The manufacturer received a confirmed customer complaint that a bottle labeled as phenobarbital 15mg was found to contain phenobarbital 30mg tablets. This mislabeled product could expose the consumer or their pet(s) to potential overdosing that can cause severe intoxication which may lead to cardiogenic shock, renal failure, coma, or death. C.O. Truxton, Inc. has not received any reports of adverse events related to this recall. The product is indicated for use as a sedative or anticonvulsant and is packaged in 1000 count bottles, NDC 0463-6160-10, UPC 7 0463616010 6, lot number 70952A, expiration date 11/17. The 15mg tablet is debossed with “West-ward 445” on one side and blank on the reverse side; the 30mg tablet is debossed with “West-ward 450” on one side and scored on the reverse side. The product was distributed nationwide in the U.S. to physician and veterinarian treatment centers. Learn more about Phenobarbital 15 mg Tablets

    StrataMR Adjustable Valves and Shunts

    Medtronic is recalling the StrataMR Adjustable Valves and Shunts due to a design problem which may cause the valve opening pressures to be higher than specified and increase the resistance to the cerebrospinal fluid flow. If this occurs, there is the potential for underdrainage of fluid. Underdrainage occurs when the cerebral spinal fluid is not removed quickly, fluid builds up in the brain cavity, and the symptoms of hydrocephalus recur. Medtronic StrataMR adjustable valves and shunts are used in the management of hydrocephalus. The device provides continuous cerebrospinal fluid flow from the ventricles of the brain into the right atrium of the heart or peritoneal cavity. The design allows the healthcare provider to non-invasively adjust the valve pressure with a magnetic tool. The use of affected product may cause serious adverse health consequences, including headaches, nausea, vomiting, coma, and death. Learn more about StrataMR Adjustable Valves and Shunts

    FDA Alerts

    Codeine and Tramadol

    The FDA is restricting the use of codeine and tramadol medicines in children. Codeine is approved to treat pain and cough, and tramadol is approved to treat pain. These medicines carry serious risks, including slowed or difficult breathing and death, which appear to be a greater risk in children younger than 12 years, and should not be used in these children. These medicines should also be limited in some older children. Single-ingredient codeine and all tramadol-containing products are FDA-approved only for use in adults. We are also recommending against the use of codeine and tramadol medicines in breastfeeding mothers due to possible harm to their infants. As a result, several label changes are required for all prescription medicines containing these drugs. These new actions further limit the use of these medicines beyond the 2013 restriction of codeine use in children younger than 18 years to treat pain after surgery to remove the tonsils and/or adenoids. Learn more about codeine and tramadol

    Erythropoiesis-Stimulating Agents

    Epoetin alfa and darbepoetin alfa are erythropoiesis-stimulating agents (ESAs), approved for the treatment of anemia (low red blood cells) resulting from chronic kidney disease, chemotherapy, and certain treatments for HIV, and to reduce the number of blood transfusions during and after certain major surgeries. ESAs work like the human protein erythropoietin, which stimulates bone marrow to make red blood cells. Epoetin alfa (marketed as Procrit and Epogen) and darbepoetin alfa (marketed as Aranesp), are manufactured by Amgen, Inc. In 2017, the FDA determined that the ESA Risk Evaluation and Mitigation Strategy (REMS), which was limited to the use of Epogen/Procrit and Aranesp to treat patients with anemia due to associated myelosuppressive chemotherapy, is no longer necessary to ensure that the benefits of Epogen/Procrit and Aranesp outweigh the risks of shortened overall survival and/or increased risk of tumor progression or recurrence in patients with cancer. The FDA made this determination based on an evaluation of the results of the REMS Assessments submitted by Amgen, Inc., and additional FDA analyses to understand the impact of the various regulatory and other actions on the use of ESAs. Learn more about ESAs

    General Anesthetic and Sedation Drugs in Young Children

    The FDA is notifying the public that we have approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include: 1) A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3 years and 2) Addition of information to the sections of the labels about pregnancy and pediatric use to describe studies in young animals and pregnant animals that showed exposure to general anesthetic and sedation drugs for more than 3 hours can cause widespread loss of nerve cells in the developing brain; and studies in young animals suggested these changes resulted in long-term negative effects on the animals’ behavior or learning. Learn more about general anesthetic and sedation drugs in young children

    Illegally Sold Cancer Treatments

    The FDA posted warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat, or cure cancer. The products are marketed and sold without FDA approval, most commonly on websites and social media platforms. The illegally sold products cited in the warning letters posted include a variety of product types, such as pills, topical creams, ointments, oils, drops, syrups, teas, and diagnostics (such as thermography devices). They include products marketed for use by humans or pets that make illegal, unproven claims regarding preventing, reversing, or curing cancer; killing/inhibiting cancer cells or tumors; or other similar anti-cancer claims. The FDA has requested responses from the 14 companies stating how the violations will be corrected. Learn more about illegally sold cancer treatments