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  • FDA Drug Updates

    FDA New Approvals

    Abrilada

    The FDA has approved Abrilada (adalimumab-afzb), the fifth biosimilar to Humira (adalimumab), for the treatment of certain patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis. Learn more about Abrilada

    Avsola

    The FDA approved Avsola (infliximab-axxq) for all indications of chronic inflammatory conditions of the reference product, Remicade (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis, moderate-to-severe Crohn's Disease in the adult and pediatric population, moderate-to-severe ulcerative colitis in the adult and pediatric population, chronic severe plaque psoriasis, psoriatic arthritis, and ankylosing spondylitis. Learn more about Avsola

    Ervebo

    The FDA has approved Ervebo (Ebola Zaire vaccine, live) for the prevention of disease caused by Zaire ebolavirus in individuals aged 18 years and older. The duration of protection conferred by Ervebo is unknown. Learn more about Ervebo

    Exservan

    The FDA has approved an oral film formulation of Exservan (riluzole) for the treatment of patients with amyotrophic lateral sclerosis. Learn more about Exservan

    Fluzone High-Dose Quadrivalent

    The FDA has approved Fluzone high-dose quadrivalent influenza vaccine for adults aged 65 years and older. Learn more about Fluzone high-dose quadrivalent

    Givlaari

    The FDA approved Givlaari (givosiran) for adults with acute hepatic porphyria. The recommended givosiran dose is 2.5mg/kg once monthly by subcutaneous injection. Learn more about Givlaari

    Nouress

    The FDA has approved Nouress (AV001), a cysteine hydrochloride injection, a critical drug for treating neonatal patients requiring total parenteral nutrition. Learn more about Nouress

    Oxbryta

    The FDA granted accelerated approval to Oxbryta (voxelotor) tablets for adults and pediatric patients aged 12 years and older with sickle cell disease. Oxbryta is an oral therapy taken once daily. Learn more about Oxbryta

    Padcev

    The FDA has granted accelerated approval to Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate. Padcev is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 or programmed death ligand 1 inhibitor and a platinum-containing chemotherapy. Learn more about Padcev

    Vyondys 53

    Accelerated approval had been granted to Vyondys 53 (golodirsen) injection to treat Duchenne muscular dystrophy (DMD) patients who have a confirmed mutation of the dystrophin gene that is amenable to exon 53 skipping. Commercial distribution of Vyondys 53 will commence immediately. Learn more about Vyondys 53

    Xcopri

    The FDA approved Xcopri (cenobamate) tablets to treat partial-onset seizures in adults. The recommended maintenance dose of Xcopri, following a titration period, is 200mg daily; however, some patients may need an additional titration to 400mg daily, the maximum recommended dose, based on their clinical response and tolerability. Learn more about Xcopri

    FDA First-Time Generic Approvals

    EluRyng

    The FDA has granted Abbreviated New Drug Application approval for EluRyng (etonogestrel/ethinyl estradiol vaginal ring), the first generic version of NuvaRing. Learn more about EluRyng

    Gilenya Generics

    The FDA has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis in adult patients. Learn more about Gilenya generics

    FDA New Indications

    Calquence

    The FDA approved Calquence (acalabrutinib) for adults with chronic lymphocytic leukemia or small lymphocytic lymphoma. The recommended dose is 100mg orally every 12 hours; it should be swallowed whole with water and with or without food. Learn more about Calquence

    Tecentriq

    The FDA approved Tecentriq (atezolizumab) in combination with paclitaxel protein-bound and carboplatin for the first-line treatment of adult patients with metastatic non-squamous non-small cell lung cancer with no EGFR or ALK genomic tumor aberrations. Learn more about Tecentriq

    Toujeo

    The FDA has expanded the indication for Toujeo (insulin glargine) 300 units/mL injection to include children as young as aged 6 years with type 1 and type 2 diabetes. The FDA first approved Toujeo in 2015 for adults with type 1 and type 2 diabetes. Learn more about Toujeo

    Vascepa

    The FDA has approved a new indication and label expansion for Vascepa (icosapent ethyl) capsules. Vascepa is indicated as an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization, and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥150mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease. Vascepa is also indicated as an adjunct to diet to reduce TG levels in adult patients with severe (≥500mg/dL) hypertriglyceridemia. Learn more about Vascepa

    Xtandi

    The FDA has approved a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC). With this approval, Xtandi is now the first and only oral treatment approved by the FDA in three distinct types of advanced prostate cancer: non-metastatic and metastatic castration-resistant prostate cancer and mCSPC. Learn more about Xtandi

    FDA Recalls

    Fagron Inc. LETS GEL KIT

    Fagron Inc. is voluntarily recalling all unexpired lots of LETS GEL KIT Convenience Packs to the hospital, pharmacy, and distributor level. The product has been found to potentially contain microbial contamination in the non-sterile suturagel methylcellulose base component. FDA analysis identified Bacillus fortis/Geobacillus toebii, Bacillus spp, and Bacillus circulans as contaminants in some samples obtained during an inspection of Fagron Inc. Learn more about the Fagron Inc. LETS GEL KIT recall

    Lannett Company, Inc. Levetiracetam Oral Solution

    Lannett Company, Inc. today announced that it is voluntarily recalling two (2) lots of levetiracetam oral solution, 100mg/mL to the consumer level due to contamination with Bacillus subtilis. The Bacillus subtilis was identified during an evaluation of a raw material used to manufacture the product. Learn more about the Lannett Company, Inc. levetiracetam oral solution recall

    Motto International Corp. Products

    Motto International Corp. is voluntarily recalling all lots of Bull Platinum 30000, Stallion Platinum 30000, Rhino 7 Platinum 30000, and Panther Platinum 30000, to the consumer level. FDA analysis has found the products to be tainted with undeclared tadalafil, which renders them unapproved drugs for which safety and efficacy has not been established and, therefore, subject to recall. Learn more about the Motto International Corp. products recall

    FDA Alerts

    Baraclude Adverse Reactions Update

    The FDA recently approved changes to the Baraclude (entecavir) tablets and oral solution product labeling. The revisions are in response to a post-marketing commitment related to a large simple safety study to assess the major clinical outcomes of death, progression of liver disease, and cancer in a broad population of HBV-infected patients using entecavir compared to standard of care over a period of 5 to 10 years of follow-up. Learn more about the Baraclude adverse reactions update

    Basic Reset and Biogenyx Drugs, Dietary Supplements, and Devices

    The FDA is alerting consumers of a recall of 25 drug, dietary supplement, and medical device product lines distributed by Basic Reset and Biogenyx. In September, a federal court entered a consent decree of permanent injunction between the US and the two companies and their owner. Under the consent decree, Basic Reset and Biogenyx must recall and stop distributing products until the companies comply with the FD&C Act and other requirements listed in the consent decree. Learn more about the Basic Reset and Biogenyx drugs, dietary supplements, and devices recall reminder

    CURE ID Infectious Disease App

    The FDA has announced the global launch of CURE ID, an internet-based repository that will allow the clinical community to report their experiences treating difficult-to-treat infectious diseases with novel uses of existing FDA-approved drugs through a website, a smartphone, or other mobile device. The platform enables the crowdsourcing of medical information from healthcare providers to guide potentially life-saving interventions and facilitate the development of new drugs for neglected diseases. The repository is a collaboration between the FDA and the National Center for Advancing Translational Sciences, which is part of the National Institutes of Health. Learn more about the FDA launching the CURE ID infectious disease app

    FDA Watch List Updated to Include Drugs with Anaphylaxis, Herpes, and Fetal Death Risk

    The FDA has updated its quarterly watch list with four dozen drugs and drug classes. The update was based on new safety information or identification of signs of serious risk, including those from conditions such as anaphylaxis, herpes zoster, and fetal death. The latest updates were created from the FDA Adverse Event Reporting System (FAERS). The six drugs/drug classes that were added to the list for potential risk of fetal death were Feraheme (ferumoxytol), Ferrlecit (sodium ferric gluconate), INFeD (iron dextran), Injectafer (ferric carboxymaltose), Venofer (iron sucrose), and generic products containing sodium ferric gluconate. Learn more about the FDA Watch List being updated to include drugs with anaphylaxis, herpes, and fetal death risk

    Gabapentinoid Side Effects

    The FDA is warning that serious breathing difficulties may occur in patients using gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR) who have respiratory risk factors. These include the use of opioid pain medicines and other drugs that depress the central nervous system, and conditions such as chronic obstructive pulmonary disease that reduce lung function. The elderly are also at higher risk. Learn more about the gabapentinoid drug safety communication

    ManErect Advisory

    The FDA is advising consumers not to purchase or use ManErect, which is a product promoted for sexual enhancement. FDA laboratory analysis confirmed that ManErect contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. This product was identified during an examination of international mail shipments. Learn more about the ManErect advisory

    PremierZEN Gold 7000 Advisory

    The FDA is advising consumers not to purchase or use PremierZEN Gold 7000, a product promoted and sold for sexual enhancement. FDA laboratory analysis confirmed that PremierZEN Gold 7000 contains sildenafil and tadalafil, the active ingredients in the FDA-approved prescription drugs Viagra and Cialis, respectively, used to treat erectile dysfunction. Learn more about the PremierZEN Gold 7000 advisory

    Ranitidine Products

    In September 2019, the FDA issued a public statement alerting that some ranitidine medicines, including Zantac OTC, could contain NDMA at low levels and asked manufacturers to conduct testing. The FDA is continuing to alert professionals and patients to voluntary recalls of ranitidine. Additionally, the agency has issued a statement regarding new testing results. Learn more about ranitidine product recalls and updates

    Shengda Advisory

    The FDA is advising consumers not to purchase or use Shengda, which is a product promoted for sexual enhancement. FDA laboratory analysis confirmed that Shengda contains sildenafil, the active ingredient in Viagra, an FDA-approved prescription drug for erectile dysfunction. This product was identified during an examination of international mail shipments. Learn more about the Shengda advisory

    Unapproved Stem Cell and Exosome Products

    The FDA is informing the public of multiple recent reports of serious adverse events experienced by patients in Nebraska who were treated with unapproved products marketed as containing exosomes. Certain clinics across the country, including some that manufacture or market illegal “stem cell” products, are now also offering exosome products to patients. The FDA is assessing the situation. Learn more about unapproved stem cell and exosome products

    Warning Letter Sent for Misbranding Vivitrol

    The FDA has posted a warning letter to Alkermes, Inc. for misbranding the drug Vivitrol (naltrexone for extended-release injectable suspension), for intramuscular use, by omitting warnings about the most serious risks associated with the drug from promotional materials. Vivitrol is approved for the prevention of relapse to opioid dependence, following opioid detoxification and should be part of a comprehensive management program that includes psychosocial support. Learn more about the warning letter sent for misbranding Vivitrol

    Warning Letters Sent to Companies Selling CBD Illegally

    The FDA has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. These particular companies are using product webpages, online stores, and social media to market CBD products in interstate commerce in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods. Learn more about warning letters sent to companies selling CBD illegally

    Warning Letter Sent to Dollar Tree

    The FDA has issued a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving OTC drugs produced by foreign manufacturers found to have serious violations of federal law. The warning letter outlines multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs as well as other drug products sold at Dollar Tree and Family Dollar stores. Learn more about the warning letter sent to Dollar Tree

    Warning Letters Sent Regarding Unapproved Umbilical Cord Blood Products

    The FDA has warned Liveyon Labs and Liveyon LLC for processing and distributing unapproved products derived from umbilical cord blood. They have also been warned regarding significant deviations from current good tissue practice and current good manufacturing practice requirements, including deficient donor eligibility practices, inadequate aseptic practices to prevent contamination, and deficient environmental monitoring. The companies’ unapproved products derived from umbilical cord blood are PURE and PURE PRO. The route of administration for the umbilical cord blood products includes intra-articular injection. Learn more about warning letters sent regarding unapproved umbilical cord blood products