FDA New Approvals
The FDA has approved Aimovig (erenumab-aooe) for the preventive treatment of migraine in adults. Aimovig is a novel therapeutic approach as the first and only FDA-approved treatment specifically developed to prevent migraine by blocking the calcitonin gene-related peptide receptor which is believed to play a critical role in migraine.
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The FDA has approved Andexxa (coagulation factor Xa [recombinant] inactivated-zhzo) to reverse the anticoagulation effects of factor Xa inhibitors when needed due to life-threatening or uncontrolled bleeding. Andexxa is a modified form of the human Factor Xa molecule, an enzyme that helps blood clot. Andexxa works by acting as a decoy for oral and injectable Factor Xa inhibitors, which target and bind to Factor Xa, which allows them to exert their anticoagulant effect. When Andexxa is given to a patient with Factor Xa inhibitor-related bleeding, it binds to the Factor Xa inhibitor and prevents it from inhibiting the activity of Factor Xa and reverses the anticoagulant effects of the inhibitor.
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The FDA has completed their Priority Review and approved Doptelet (avatrombopag) for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. This represents the first thrombopoietin receptor agonist approved in the US for this indication.
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The FDA has approved Jynarque (tolvaptan) to slow decline in kidney function in adults at risk for rapidly progressing autosomal dominant polycystic kidney disease.
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The FDA approved Kymriah (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunotherapy, for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.
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The FDA has approved Lokelma (sodium zirconium cyclosilicate), formerly ZS-9, for the treatment of adults with hyperkalemia. Lokelma is an insoluble, non-absorbed sodium zirconium silicate, formulated as a powder for oral suspension, which acts as a highly-selective potassium-removing agent. It is administered orally, is odorless, tasteless and stable at room temperature.
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The FDA approved Lucemyra (lofexidine hydrochloride) for the mitigation of withdrawal symptoms to facilitate abrupt discontinuation of opioids in adults. While Lucemyra may lessen the severity of withdrawal symptoms, it may not completely prevent them and is only approved for treatment for up to 14 days. Lucemyra is not a treatment for opioid use disorder (OUD) but can be used as part of a broader, long-term treatment plan for managing OUD.
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The FDA approved Plenvu (polyethylene glycol 3350, sodium ascorbate, sodium sulfate, ascorbic acid, sodium chloride, and potassium chloride for oral solution), a lower-volume, 1-liter bowel cleansing preparation for colonoscopies. The product is intended to reduce one of the biggest deterrents for patients in completing the preparation. It is expected to be available in the US in the third quarter of this year.
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The FDA cleared Pluristem’s PLX-R18 therapy for treating radiation exposure in an emergency situation. Pluristem is still seeking full approval of the drug based on the results of a Phase 3 clinical trial and is in discussions with the FDA and several other agencies to organize a study. It previously completed a mid-stage study sponsored by the NIH’s National Institute of Allergy and Infectious Diseases. The Department of Defense is also studying the drug for its potential to support service members within the first 24 hours of radiation exposure. PLX-R18 will be provided up to 96 hours following radiation exposure.
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The FDA has given full approval to Praxbind (idarucizumab) to reverse the anticoagulant effect of Pradaxa (dabigatran) in the event of urgent surgery or life-threatening or uncontrolled bleeding. The FDA granted accelerated approval to the monoclonal antibody fragment in October 2015, with continued approval contingent upon the results of the recently completed RE-VERSE AD trial.
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FDA approved Retacrit (epoetin alfa-epbx)
as a biosimilar to Epogen/Procrit (epoetin alfa) for the treatment of anemia
due to chronic kidney disease in patients on dialysis and not on dialysis, use
of zidovudine in patients with HIV infection, and the effects of concomitant
myelosuppressive chemotherapy. It is also
approved for the reduction of allogeneic red blood cell transfusions in
patients undergoing elective, noncardiac, nonvascular surgery.
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The FDA approved Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
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The FDA approved Tavalisse (fostamatinib disodium hexahydrate tablets) for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. Tavalisse is an oral spleen tyrosine kinase inhibitor that targets the underlying autoimmune cause of the disease by impeding platelet destruction, providing an important new treatment option for adult patients with chronic ITP.
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FDA New Indications
The FDA has approved the use of Arnuity Ellipta (fluticasone furoate) a once-daily inhaled corticosteroid medicine for the maintenance treatment of asthma in children from as young as 5 years. This makes Arnuity one of the few once-daily treatments for asthma licensed in the US in this younger age group.
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Briviact (brivaracetam) oral formulations are now approved by the FDA to treat partial-onset (focal) seizures in pediatric epilepsy patients age four years and older. As the safety of Briviact injection has not been established in pediatric patients, Briviact injection is indicated for the treatment of partial-onset seizures only in patients 16 years of age and older.
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Darzalex Plus Bortezomib, Melphalan and Prednisone
The FDA has approved Darzalex (daratumumab) in combination with Velcade (bortezomib), a proteasome inhibitor; melphalan, an alkylating agent; and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Darzalex is the first monoclonal antibody approved for newly diagnosed patients with this disease.
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The FDA has expanded approval for Gilenya (fingolimod) to the treatment of children and adolescents with relapsing multiple sclerosis (MS) who are aged 10 years or older, the first such approval of a drug to treat MS in pediatric patients.
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The FDA has approved Kymriah (tisagenlecleucel) suspension for intravenous infusion for its second indication, the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma. Kymriah is not indicated for the treatment of patients with primary central nervous system lymphoma.
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Myrbetriq Plus Vesicare
The FDA has approved Myrbetriq (mirabegron) in combination with Vesicare (solifenacin succinate) for the treatment of overactive bladder (OAB) accompanied by symptoms of urge urinary incontinence, urgency, and urinary frequency. The approval follows consideration of data from three large, global phase 3 trials that compared combination therapy with monotherapy: SYNERGY I, SYNERGY II, and BESIDE.
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Opdivo Plus Yervoy
The FDA approved Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of intermediate or poor risk, previously untreated advanced renal cell carcinoma.
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Tafinlar Plus Mekinist
The FDA approved Tafinlar (dabrafenib) and Mekinist (trametinib) in combination for the treatment of patients with locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation and with no satisfactory locoregional treatment options. This combination was also approved for the adjuvant treatment of patients with melanoma with BRAF V600E or V600K mutations, as detected by an FDA-approved test, and involvement of lymph node(s), following complete resection.
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The FDA has approved an expanded indication for Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) to include a broader population of chronic obstructive pulmonary disease (COPD) patients with airflow limitation or who have experienced an acute worsening of respiratory symptoms. The new indication is for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations. It is not indicated for relief of acute bronchospasm or for the treatment of asthma.
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The FDA has approved once-daily oral Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg), in combination with safer sex practices, to reduce the risk of sexually acquired HIV-1 in at-risk adolescents weighing at least 35kg.
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AuroMedics Pharma Ampicillin and Sulbactam for Injection, USP 3g
AuroMedics Pharma is voluntarily recalling two lots of ampicillin and sulbactam for injection USP, 3g/single-dose vials, to the hospital/user level. The recall has been initiated due to customer complaints of the presence of red particulate matter in the product that is believed to be red rubber particles from the manufacturing process of the active ingredients. It is packaged in a carton containing 10 vials, NDC 55150-117-20. The affected ampicillin and sulbactam for injection lots being recalled are AS0317041-A, Exp. Aug 2019, and AS0317035-A, Exp. Aug 2019.
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AuroMedics Pharma Piperacillin and Tazobactam for Injection, USP 3.375g
AuroMedics Pharma is voluntarily recalling two lots of piperacillin and tazobactam for injection, USP 3.375g (piperacillin sodium equivalent to 3g of piperacillin USP and tazobactam sodium equivalent to 0.375g of tazobactam USP. Each vial contains 7.05mEq (162mg) of sodium in a single-dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. It is packaged in a carton containing 10 single-dose vials, NDC: 55150-120-30. The affected piperacillin and tazobactam for injection lots being recalled are PP0317061-A, Exp. Aug 2019, and PP0317049-A, Exp. Aug 2019.
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Badger Botanicals, LLC Kratom Dietary Supplements
Badger Botanicals, LLC is recalling Green Suma, Red Suma, Green Hulu 2, and Red Hulu 2
kratom dietary supplements sold directly to consumers via the company website
from January 1, 2018 to April 12, 2018 in pouches of 250g, because it has the
potential to be contaminated with Salmonella.
Learn more about the Badger Botanicals, LLC kratom dietary supplements recall
CSL Behring Kcentra 1000 U Prothrombin Complex Concentrate
CSL Behring is notifying customers of a potential risk of breakage of the glass vials with respect to three (3) Kcentra lots, which were distributed until March 2018. There is an increased risk of breakage during transport and handling of the product due to a change in the secondary packaging configuration in January 2018. Only Kcentra 1000 U lots M9560111E, N1260111A and N1360111A are subject to this notification.
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Ethanol Extraction Alcohol Product
Lake Michigan Distilling Company, LLC, doing business as Ethanol Extraction, is recalling its 95% ethyl alcohol product (“Product”) because of possible contamination with methanol, a highly toxic type of alcohol that can cause serious and sometimes fatal damage if ingested by humans or animals. Ethanol Extraction’s Product was sold through the company’s website and delivered by direct shipment throughout the US. The Product was sold in various size plastic bottles, ranging from 8 oz to 1 gallon, as well as 2.5-gallon and 5-gallon containers. The Product was first sold in October 2016 and last sold on April 30, 2018. All bottles and containers of the Product are being recalled.
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MBI Distributing, Inc. Homeopathic Products
MBI Distributing, Inc. is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, to the consumer level. The drug products have been found to be manufactured with a lack of adequate controls. These homeopathic drug products are in liquid oral dosage form and are packaged in sizes from 1 fluid ounce to 8 fluid ounces.
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Shoreside Enterprises 7K and Poseidon 4500 (Extreme 1000mg)
Shoreside Enterprises, Inc. is voluntarily recalling 7K (Lot specific: Lot #RO) and Poseidon 4500 (Extreme 1000mg) (Lot specific: Lot #20117BL) to the consumer level. FDA analysis found the samples of these products to contain undeclared sildenafil and/or tadalafil. The products are marketed as dietary supplements for male sexual enhancement. The products can also be identified by their blue color, and lot numbers are located on their individual packaging. These products are packaged in 1 capsule blister packs. These products were distributed from February 2, 2017 to December 19, 2017, to retail locations in Illinois, Ohio, North Carolina, Massachusetts, and Florida by Shoreside Enterprises.
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Viable Solutions Kratom-containing Powder Products
Viable Solutions has initiated a recall of certain Kratom-containing powder products because it has the potential to be
contaminated with Salmonella. The potentially affected
powder products are packaged in craft paper, foil-lined heat-sealed pouches and
sold in 25g, 100g, 250g, and 1000g sizes. The lot numbers being recalled can be found on the packaging
and are RVS1380182301, RVB1380182201, GVH1380171512, and MD13120181601.
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Lamictal Tied to Serious Immune System Reaction
The FDA is warning that the medicine Lamictal (lamotrigine) for seizures and bipolar disorder can cause a rare but very serious reaction that excessively activates the body’s infection-fighting immune system. This can cause severe inflammation throughout the body and lead to hospitalization and death, especially if the reaction is not diagnosed and treated quickly. The immune system reaction, called hemophagocytic lymphohistiocytosis (HLH), causes an uncontrolled response by the immune system. HLH typically presents as a persistent fever, usually greater than 101°F, and it can lead to severe problems with blood cells and organs throughout the body such as the liver, kidneys, and lungs.
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Tecentriq or Keytruda Monotherapy Associated with Decreased Survival in Clinical Trials
The FDA is alerting healthcare professionals, oncology clinical investigators and the public about decreased survival associated with the use of Tecentriq (atezolizumab) or Keytruda (pembrolizumab) as single therapy (monotherapy) in clinical trials to treat patients with metastatic urothelial cancer who have not received prior therapy and who have low expression of the protein programmed death ligand 1 (PD-L1). In two ongoing clinical trials (KEYNOTE-361 and IMVIGOR-130), the Data Monitoring Committees’ early reviews found patients in the monotherapy arms of both trials with PD-L1 low status had decreased survival compared to patients who received cisplatin- or carboplatin-based chemotherapy.
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