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  • FDA Drug Updates

    FDA New Approvals


    The FDA has approved Ajovy (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. Ajovy, a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor, is the first and only anti-CGRP treatment for the prevention of migraine with quarterly (675mg) and monthly (225mg) dosing options. Learn more about Ajovy


    The FDA has approved once-daily Altreno (tretinoin) 0.05% lotion for treatment of acne vulgaris in patients aged 9 years and older, making it the first tretinoin product to be available in lotion form. Learn more about Altreno


    The FDA approved Cassipa (buprenorphine and naloxone) sublingual film for the maintenance treatment of opioid dependence. This action provides a new dosage strength (16mg/4mg) of buprenorphine and naloxone sublingual film, which is also approved in both brand name and generic versions and in various strengths. Learn more about Cassipa


    The FDA approved Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) as a complete regimen for the treatments of adults with HIV-1 infection with no prior antiretroviral treatment history. Delstrigo is a once-daily fixed-dose combination that can be taken with or without food. Learn more about Delstrigo


    The FDA has approved a new formulation of GamaSTAN (human immune globulin) for prophylaxis following exposure to hepatitis A virus (HAV) and for prevention or modification of measles in susceptible individuals exposed fewer than 6 days previously. The new formulation is manufactured using a caprylate chromatography process. In addition to HAV and measles, GamaSTAN is also approved for rubella and varicella postexposure prophylaxis. Learn more about GamaSTAN


    The FDA approved Inveltys (loteprednol etabonate) 1% ophthalmic suspension for the treatment of pain and inflammation following eye surgery. It is the first topical ocular corticosteroid with twice-daily dosing rather than standard four-times-a-day dosing. Learn more about Inveltys


    The FDA has approved Jivi (antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and in children and adolescents aged 12 years or older. Jivi is also indicated for on-demand treatment and the perioperative management of bleeding in the same patient population. The initial recommended prophylactic regimen for Jivi is twice weekly; it can be administered every 5 days and can be further adjusted individually to less or more frequent dosing, based on bleeding episodes. Learn more about Jivi


    The FDA approved Lumoxiti (moxetumomab pasudotox-tdfk) a CD22-directed cytotoxin indicated for adult patients with relapsed or refractory hairy cell leukemia who received at least two prior systemic therapies, including treatment with a purine nucleoside analogue. Learn more about Lumoxiti


    The FDA has approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis, a rare disease affecting the cornea. Learn more about Oxervate


    The FDA approved Pifeltro (doravirine) for the treatments of adults with HIV-1 infection with no prior antiretroviral treatment history. Pifeltro is a new non-nucleoside reverse transcriptase inhibitor to be given in combination with other antiretroviral medicines, and it is taken once daily with or without food. Learn more about Pifeltro


    The FDA approved Takhzyro (lanadelumab-flyo), the first monoclonal antibody (mAb) approved in the US to treat patients 12 years and older with types I and II hereditary angioedema (HAE). Takhzyro is the only mAb that provides targeted inhibition of plasma kallikrein, an enzyme which is chronically uncontrolled in people with HAE, to help prevent attacks. The recommended starting dose of Takhzyro is 300mg every two weeks. A dosing interval of 300mg every four weeks is also effective and may be considered if the patient is well-controlled (eg, attack free) for more than six months. Learn more about Takhzyro


    The FDA has approved Tiglutik (riluzole) liquid form for patients with amyotrophic lateral sclerosis (ALS). Tiglutik is the first and only easy-to-swallow thickened riluzole liquid for ALS and is administered twice daily via an oral syringe. Learn more about Tiglutik


    The FDA approved Xerava (eravacycline), a fluorocycline antibacterial within the tetracycline class of antibacterial drugs, for the treatment of complicated intra-abdominal infections in patients aged 18 years and older. Xerava is not indicated for the treatment of complicated urinary tract infections. Learn more about Xerava

    FDA New Indications


    The FDA has approved Imbruvica (ibrutinib) in combination with rituximab for the treatment of Waldenstrom’s macroglobulinemia (WM), a rare blood cancer. The approval expands the label for Imbruvica in WM beyond its current approved use as a monotherapy to include combination use with rituximab. This approval represents the first approved non-chemotherapy combination option for the treatment of WM. Learn more about Imbruvica


    The FDA has expanded the indication for the cystic fibrosis (CF) drug Kalydeco (ivacaftor) to children aged 12 to <24 months who have at least one mutation in the CF transmembrane conductance regulator gene that is responsive to the drug, as determined on the basis of clinical or in vitro assay data. Learn more about Kalydeco


    The FDA granted accelerated approval to Opdivo (nivolumab) for patients with metastatic small cell lung cancer with progression after platinum-based chemotherapy and at least one other line of therapy. Learn more about Opdivo

    FDA Recalls

    Accord HCTZ 12.5mg Tablets

    Accord is voluntarily recalling one lot (Lot PW05264 – 46632 Bottles, NDC 16729-182-01) of HCTZ tabs USP, 12.5mg, to the consumer level. A 100-count bottle of HCTZ tabs USP 12.5mg has been found to contain 100 spironolactone tabs USP, 25mg. Learn more about the Accord HCTZ tabs recall

    Beaumont Bio Med Aqueous/Alcohol-Based Products

    Beaumont Bio Med is voluntarily recalling its entire aqueous/alcohol-based product line for human use, within expiry, to the consumer level. All products manufactured by the contract manufacturer, King Bio, have been recalled due to possible microbial contamination. Learn more about the Beaumont Bio Med aqueous/alcohol-based products recall

    BioLyte Laboratories NeoRelief for Muscle Cramping and Restlessness Topical Gel

    BioLyte Laboratories is voluntarily recalling lot numbers 1138, 1139, 1146, and 1160 of NeoRelief for Muscle Cramping and Restlessness Topical Gel to the retail and consumer level. King Bio, a manufacturer of some of the active ingredients in this product, has been found to have some water contamination issues that potentially could have affected this product. King Bio has issued a recall of these active ingredients in BioLyte’s lot-specific product. Learn more about the BioLyte Laboratories NeoRelief topical gel recall

    Camber Pharmaceuticals Montelukast 10mg Tablets

    The FDA is warning consumers and healthcare professionals about a voluntary recall of one lot of montelukast sodium tabs – lot number MON17384, expiration 12/31/2019 – by Camber Pharmaceuticals. Sealed bottles labeled as montelukast sodium tabs, 10mg, 30-count bottle from Camber were found to instead contain 90 tabs of losartan potassium tabs, 50mg. Learn more about the Camber Pharmaceuticals montelukast tablet recall

    HelloLife Products

    HelloLife is initiating a voluntary recall of four different products, Neuroveen, Respitrol, Thyroveev, and Compulsin, within expiry, to the retail and consumer level due to possible microbial contamination. Neuroveen has been tested and found to be contaminated with Staphylococcus saprophyticus and Burkholderia cepacia. Compulsin has been identified as containing B. cepacia. Respitrol and Thyroveev are still pending bacterial identification. Learn more about the HelloLife products recalls

    King Bio Aqueous-Based Products

    King Bio is voluntarily recalling all of its aqueous-based products for human and animal use, within expiry, to the consumer level due to possible microbial contamination. King Bio is notifying its distributors and customers by letter and is arranging for return and/or replacement of all recalled products. Consumers/distributors/retailers that have product which is being recalled should discontinue use/distribution and contact King Bio to make arrangements to return product. These products were distributed nationwide to distributors and retail stores through August 24, 2018. Learn more about the King Bio recall

    Living Well Remedies Weight Away Remedy

    Living Well Remedies is voluntarily recalling Weight Away Remedy lot# 111417LWL614 to the consumer level. The independent manufacturing facility that produced this lot reported it to be out of specification for microbial testing. Weight Away Remedy is a homeopathic spray intended to help with weight loss and is packaged in a 2-oz spray bottle. Living Well Remedies has already notified the consumers that purchased the product and is arranging for refund or replacement. Learn more about the Living Well Remedies Weight Away Remedy recall

    Pfizer Consumer Healthcare Children’s Advil Suspension

    Pfizer Consumer Healthcare, a division of Pfizer Inc., is voluntarily recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 fl oz bottle because of customer complaints that the dosage cup provided is marked in teaspoons and the instructions on the label are described in milliliters. Children’s Advil Suspension Bubble Gum Flavored 4 fl oz bottle, NDC 0573-0207-30, lot R51129 was distributed nationwide to wholesalers, distributors, and retailers in the US from May 2018 through June 2018. Learn more about the Pfizer Consumer Healthcare Children’s Advil suspension recall

    Pharm D Solutions Sterile Compounded Drugs

    Pharm D Solutions is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician, or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. Learn more about the Pharm D Solutions sterile compounded drugs recall

    Product Quest Manufacturing Nasal Products and Baby Oral Gels

    Product Quest Manufacturing announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal Mist due to a finding of microbial contamination identified as Pseudomonas aeruginosa. Out of an abundance of caution, Product Quest has decided to expand the recall to include all lots of nasal products and baby oral gels currently within expiration that were manufactured at the company’s Florida facility. Learn more about the Product Quest Manufacturing nasal products and baby oral gels recall

    SCA Pharmaceuticals Furosemide in Sodium Chloride

    SCA Pharmaceuticals is voluntarily recalling 7 lots of the injectable product furosemide 100mg in 0.9% sodium chloride 100mg bag to the consumer level. This product is being recalled for visible particulate matter believed to be furosemide precipitate. Learn more about the SCA Pharmaceuticals furosemide in sodium chloride recall

    FDA Alerts

    EpiPen Expiration Date Extension

    The FDA took additional action to mitigate shortages of EpiPen (epinephrine) auto-injector by extending the expiration date of specific lots of 0.3mg products marketed by Mylan by four months beyond the labeled expiration date. This change beyond the approved 20-month shelf life is based on stability data provided by Mylan and reviewed by the FDA. To help ensure patient safety, these products, which already have been dispensed to patients, should have been and should continue to be stored as labeled. Learn more about EpiPen expiration date extension

    FDA Takes Action Against Websites Marketing Unapproved Opioids

    The FDA announced it has warned four more online networks, operating a total of 21 websites, illegally marketing potentially dangerous, unapproved, and misbranded versions of opioid medications, including tramadol. The warning letters issued by the FDA to each of the networks state that they must immediately stop illegally selling these products to American consumers. The networks receiving warning letters include CoinRX, MedInc.biz, PharmacyAffiliates.org, and PharmaMedics. Learn more about the FDA taking action against websites marketing unapproved opioids

    Keytruda and Tecentriq Companion Test Requirements

    The FDA has updated the prescribing information for Keytruda (pembrolizumab) and Tecentriq (atezolizumab) to require the use of an FDA-approved companion diagnostic test, Dako PD-L1 IHC 22C3 PharmDx Assay and Ventana PD-L1 (SP142) Assay respectively, to determine PD-L1 levels in tumor tissue from patients with locally advanced or metastatic urothelial cancer who are cisplatin-ineligible. Learn more about Keytruda and Tecentriq companion test requirements

    King Bio Products

    The FDA is warning consumers and pet owners not to use drug products, including homeopathic drug products, made by King Bio Inc. and labeled as Dr. King’s, as these products may pose a safety risk to people (especially infants, children, pregnant women, and those with compromised immune systems), as well as pets, due to high levels of microbial contamination identified at the manufacturing site. Learn more about the King Bio products alert

    Potential Risk of Neural Tube Birth Defects with Dolutegravir

    The FDA is alerting the public that serious cases of neural tube birth defects involving the brain, spine, and spinal cord have been reported in babies born to women treated with dolutegravir used to treat HIV. Preliminary results from an ongoing observational study in Botswana found that women who received dolutegravir at the time of becoming pregnant or early in the first trimester appear to be at higher risk for these defects. This information has been addressed in product labeling. Learn more about the potential risk of neural tube birth defects with dolutegravir

    SGLT2 Inhibitors for Diabetes: Rare Occurrences of a Serious Genital Infection

    FDA is warning that cases of a rare but serious infection of the genitals and area around the genitals have been reported with SGLT2 inhibitors. This serious rare infection, called necrotizing fasciitis of the perineum, is also referred to as Fournier’s gangrene. The FDA is requiring a new warning about this risk to be added to the prescribing information of all SGLT2 inhibitors and to the patient Medication Guide. Learn more about the SGLT2 inhibitors genital infection warning

    Years to Your Health Products Alert

    The FDA is alerting consumers not to use any products made by Years to Your Health of Irving, Texas. The FDA is concerned these products could put consumers at risk for serious infection because they are made in a facility with poor manufacturing practices. Years to Your Health markets hundreds of products online and in its retail store. Learn more about the Years to Your Health products alert