FDA New Approvals
The FDA has approved Sevenfact (coagulation factor VIIa [recombinant]-jncw) for the treatment and control of bleeding episodes occurring in adults and adolescents aged 12 years and older with hemophilia A or B with inhibitors (neutralizing antibodies). Sevenfact contains an active ingredient expressed in genetically engineered rabbits.
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The FDA has approved Zeposia (ozanimod) 0.92mg as an oral treatment for relapsing forms of multiple sclerosis. Zeposia can be used to treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
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FDA Labeling Changes
SGLT2 Inhibitors Before Scheduled Surgery
The FDA has approved safety labeling changes to sodium glucose co-transporter-2 (SGLT2) inhibitors for type 2 diabetes. Invokana (canagliflozin), Farxiga (dapagliflozin), and Jardiance (empagliflozin) should each be discontinued at least three days before scheduled surgery. Steglatro (ertugliflozin) should be discontinued at least four days before scheduled surgery. These discontinuations are to lessen the risk of developing ketoacidosis after surgery. Blood glucose levels should be carefully monitored after discontinuation of the SGLT2 inhibitor and appropriately managed before surgery.
Learn more about label changes to SGLT2 inhibitors
FDA New Indications
The FDA approved changes to Epclusa (sofosbuvir and velpatasvir) labeling to provide for the use in pediatric patients with chronic hepatitis C virus (HCV) aged 6 years and older or weighing at least 37 pounds (17 kg) with any of the six HCV genotypes, or strains, without cirrhosis or with mild cirrhosis. Epclusa in combination with ribavirin is indicated for the treatment of pediatric patients aged 6 years and older or weighing at least 37 lb with severe cirrhosis.
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The FDA approved Imfinzi (durvalumab) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC). For ES-SCLC, Imfinzi is to be administered prior to chemotherapy on the same day. Durvalumab is already approved for unresectable, stage 3 non-small cell lung cancer in patients whose disease has not progressed following concurrent chemotherapy and radiation therapy. It is also approved for use in urothelial cancer.
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Opdivo and Yervoy
The FDA granted accelerated approval to the combination of Opdivo (nivolumab) and Yervoy (ipilimumab) for patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. For HCC, the recommended doses are nivolumab 1mg/kg followed by ipilimumab 3mg/kg on the same day every 3 weeks for 4 doses, then nivolumab 240mg every 2 weeks or 480mg every 4 weeks.
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The FDA has approved Reblozyl (luspatercept-aamt), the first and only erythroid maturation agent, for the treatment of anemia failing an erythropoiesis-stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis. Reblozyl is also approved for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell transfusions. It is not indicated for use as a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
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The FDA has approved new indications for Sotalol IV in AFib patients. Sotalol IV is now approved for 1-day hospital outpatient initiation of AFib therapy and faster dose escalations for existing patients. The new FDA-approved dosing, monitoring, and evaluation shorten the hospital stay from 3 days to 1 day.
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FDA New Dosing
The FDA has approved a New Drug Application for an intravenous formulation of Triferic, Triferic AVNU (ferric pyrophosphate citrate). With this approval, Triferic AVNU joins Triferic Dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace iron lost during every dialysis treatment and maintain hemoglobin. While Triferic Dialysate is designed to be administered via liquid bicarbonate, Triferic AVNU is designed for direct intravenous infusion, which provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians. Triferic AVNU can be administered regardless of a dialysis center’s mode of bicarbonate delivery.
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Dr. Reddy’s Laboratories Ltd. Phytonadione Injectable Emulsion
Dr. Reddy’s Laboratories Ltd. announced that it is voluntarily recalling four lots (ACB902, ACB903, ACB904, ACB905) of phytonadione injectable emulsion USP, 10mg/mL, single-dose ampules to the hospital level. The product is being recalled due to product complaints received due to ampules breaking and shattering, upon opening, during compounding.
Learn more about the Dr. Reddy’s Laboratories Ltd. phytonadione injectable emulsion recall
Mountain Rose Herbs Kudzu Root Herbal Supplement
Mountain Rose Herbs is recalling all sizes of its Organic Kudzu Root Herbal Supplement from lots #24247-X and #24247 because they have the potential to be contaminated with Salmonella. The product comes in a clear plastic or poly-woven bag, has net weight ranges from 4 oz to 50 lb, and is marked with lot #24247-XExternal Link Disclaimer and #24247External Link Disclaimer. The lot number is located on the principal display panel on the lower left of the label.
Learn more about the Mountain Rose Herbs Kudzu Root Herbal Supplement recall
Natural Remedy Store Active Male
Natural Remedy Store is voluntarily recalling all lots of Active Male 500mg capsules to the consumer level. FDA analysis has found the product to be tainted with undeclared tadalafil.
Learn more about Natural Remedy Store Active Male recall
Chloroquine Phosphate Intended for Fish
The FDA’s Center for Veterinary Medicine has recently become aware that some consumers may mistake chloroquine phosphate used to treat disease in aquarium fish for FDA-approved drugs (used to treat malaria and certain other conditions in humans) that are being studied as a COVID-19 treatment for humans. Chloroquine products sold for aquarium use have not been evaluated by the FDA to determine whether they are safe, effective, properly manufactured, and adequately labeled for use in fish—let alone humans. Products marketed for veterinary use, “for research only,” or otherwise not for human consumption have not been evaluated for safety in humans. Do not take any form of chloroquine unless it has been prescribed for you by your healthcare provider and obtained from legitimate sources.
Learn more about chloroquine phosphate intended for fish
EpiPen and EpiPen Jr Auto-Injector Errors and Malfunctions
The FDA is alerting patients, caregivers, and healthcare professionals that EpiPen (epinephrine) 0.3mg and EpiPen Jr (epinephrine) 0.15mg auto-injectors, and the authorized generic versions, may potentially have delayed injection or be prevented from properly injecting due to device failure from spontaneous activation caused by using sideways force to remove the blue safety release; device failure from inadvertent or spontaneous activation due to a raised blue safety released; difficulty removing the device from the carrier tube; or user errors.
Learn more about EpiPen and EpiPen Jr auto-injector errors and malfunctions
Fecal Microbiota for Transplantation Has Potential for Risk of Transmission of SARS-CoV-2
The FDA is informing healthcare providers and patients of the potential risk of transmission of SARS-CoV-2 virus by the use of fecal microbiota for transplantation (FMT) (a procedure that transfers stool from a healthy donor via colonoscopy, enema, nasogastric tube, or capsule form) and that the FDA has determined that additional safety protections are needed. Several recent studies have documented the presence of SARS-CoV-2 RNA and/or SARS-CoV-2 virus in stool of infected individuals. This information suggests that SARS-CoV-2 may be transmitted by FMT, although the risk of such transmission is unknown. At this time, testing nasopharyngeal specimens from stool donors for SARS-CoV-2 may not be widely available. Furthermore, there is limited information on the availability and sensitivity of direct testing of stool for SARS-CoV-2.
Learn more about the fecal microbiota for transplantation safety alert
Herbal Doctor Remedies Products
The FDA issued a reminder not to use any drugs manufactured by Herbal Doctor Remedies because these drugs were not manufactured under good manufacturing practices. During the FDA’s March 2020 follow-up inspection, investigators observed continued insanitary conditions and numerous serious violations of current good manufacturing practices at the Herbal Doctor Remedies facility. On March 23, the FDA recommended Herbal Doctor Remedies recall all unexpired drugs, and the company agreed.
Learn more about the reminder not to use products by Herbal Doctor Remedies
Insulin Gains New Pathway to Increased Competition
The FDA announced that certain biologic drugs including insulin will be transitioning to a different regulatory pathway. This regulatory transition, mandated by Congress and implemented by the FDA, will open the pathway for products that are proposed as biosimilar to, or interchangeable with, the transitioned products. The availability of safe and effective biosimilar and interchangeable versions of these treatments, including insulin, is expected to increase patient access, adding more choices and potentially reducing costs of these vital therapies.
Learn more about insulin gaining a new pathway to increased competition
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) for COVID-19
The FDA is aware of news reports stating the use of NSAIDs such as ibuprofen could worsen coronavirus disease (COVID-19). These news reports followed a March 11, 2020 letter in The Lancet medical journal, which hypothesized that an enzyme is increased by NSAIDs and could aggravate COVID-19 symptoms. At this time, the FDA is not aware of scientific evidence connecting the use of NSAIDs, like ibuprofen, with worsening COVID-19 symptoms. The agency is investigating this issue further and will communicate publicly when more information is available.
Learn more about the use of NSAIDs for COVID-19
Ranitidine (Zantac) Removal from Market
The FDA announced it is requesting manufacturers withdraw all prescription and over-the-counter ranitidine drugs from the market immediately. This is the latest step in an ongoing investigation of a contaminant known as N-Nitrosodimethylamine (NDMA) in ranitidine medications. The agency has determined that the impurity in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity. As a result of this immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the US.
Learn more about the FDA requesting removal of all ranitidine (Zantac) products from the market