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  • FDA Drug Updates

    FDA New Approvals

    Darzalex Faspro

    The FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj), a new subcutaneous formulation of daratumumab. Darzalex Faspro is approved in four regimens across five indications in multiple myeloma patients, including newly diagnosed, transplant-ineligible patients as well as relapsed or refractory patients. As a fixed-dose formulation, Darzalex Faspro can be administered over approximately three to five minutes, significantly less time than Darzalex, which is given intravenously over hours. Learn more about Darzalex Faspro


    The FDA has approved Elyxyb (celecoxib) oral solution 25mg/mL. Elyxyb (previously known as DFN-15) is indicated for the acute treatment of migraine with or without aura in adults. Learn more about Elyxyb


    The FDA approved Emerphed (ephedrine), the first and only premixed ephedrine in a ready-to-use 50mg/10mL vial. Emerphed will be available in a ready-to-use 10mL vial that does not require further dilution. Each vial contains 50mg ephedrine sulfate in 0.9% sodium chloride. Learn more about Emerphed


    The FDA has approved a New Drug Application for Fensolvi (leuprolide acetate) for injectable suspension for the treatment of pediatric patients two years of age and older with central precocious puberty (CPP). Fensolvi utilizes a proprietary polymeric gel technology that forms an in-situ solid after injection and releases leuprolide acetate in a sustained and controlled manner over time. This polymeric gel technology enables a small volume of injection of only 0.375mL, subcutaneous administration, and a six-month dosing cycle. Learn more about Fensolvi


    The FDA approved Jelmyto (mitomycin), the first therapy to treat low-grade upper tract urothelial cancer. It has been designed to enable longer exposure of urinary tract tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. Learn more about Jelmyto


    The FDA approved Koselugo (selumetinib) for pediatric patients, aged 2 years and older, with neurofibromatosis type 1 who have symptomatic, inoperable plexiform neurofibromas. Koselugo, a kinase inhibitor, is the first therapy approved for pediatric patients who have this debilitating, and often disfiguring, rare disease. Learn more about Koselugo


    The FDA approved Ongentys (opicapone) as add-on therapy for patients with Parkinson’s disease who experience “off” periods while receiving a stable levodopa/carbidopa regimen. Ongentys is a once-daily, oral, peripheral, selective, and reversible catechol-O-methyltransferase inhibitor. Learn more about Ongentys


    The FDA granted accelerated approval to Pemazyre (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor fusion or other rearrangement as detected by an FDA-approved test. Pemazyre is the first and only FDA-approved treatment for this indication, which was approved under accelerated approval based on overall response rate and duration of response. Continued approval may be contingent on verification and description of clinical benefit in a confirmatory trial(s). Learn more about Pemazyre


    The FDA has approved ed Retevmo (selpercatinib), the first therapy specifically indicated for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer, and the treatment of adult and pediatric patients aged 12 years and older with advanced or metastatic RET-mutant medullary thyroid cancer who require systemic therapy, or advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate). Learn more about Retevmo


    The FDA has now approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer whose tumors have a mutation that leads to MET exon 14 skipping as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Learn more about Tabrecta


    The FDA granted accelerated approval to Trodelvy (sacituzumab govitecan-hziy) for adult patients with metastatic triple-negative breast cancer (TNBC) who received at least two prior therapies for metastatic disease. Trodelvy is the first antibody-drug conjugate (ADC) approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC. Learn more about Trodelvy


    The FDA approved Tukysa (tucatinib) in combination with trastuzumab and capecitabine for adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. This is the first drug approved by the FDA under international collaboration. Learn more about Tukysa

    FDA First-Time Generic Approvals

    Proventil HFA

    The FDA approved the first generic of Proventil HFA (albuterol sulfate) metered-dose inhaler, 90mcg/inh, for the treatment or prevention of bronchospasm in patients aged 4 years and older who have reversible obstructive airway disease, as well as the prevention of exercise-induced bronchospasm in this age group. Learn more about the first generic Proventil HFA

    FDA New Indications


    The FDA approved Braftovi (encorafenib) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer with a BRAFV600E mutation, detected by an FDA-approved test, after prior therapy. Braftovi is already approved for use in BRAF-positive metastatic melanoma. Learn more about Braftovi


    Farxiga (dapagliflozin) has been approved in the US to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). Farxiga is the first sodium glucose co-transporter 2 inhibitor approved by the FDA indicated to treat patients with HFrEF. Farxiga is also indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Learn more about Farxiga


    The FDA expanded the indication of Imbruvica (ibrutinib) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma. This is the eleventh FDA approval for Imbruvica since it was first approved in 2013 and the sixth in CLL, the most common form of leukemia in adults. Learn more about Imbruvica

    FDA New Dosing


    The FDA granted accelerated approval to an additional dosing regimen of 400mg every six weeks for Keytruda (pembrolizumab) across all currently approved adult indications, including monotherapy and combination therapy. Keytruda is an anti-PD-1 therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. Learn more about Keytruda

    FDA Recalls

    Amneal Pharmaceuticals Nizatidine Oral Solution

    Amneal Pharmaceuticals is voluntarily recalling three lots (06598004A, 06599001A, 06599002A) of nizatidine oral solution, 15mg/mL (75mg/5mL), packaged in 480mL bottles, to the consumer level. Nizatidine oral solution is being recalled due to potential N-Nitrosodimethylamine amounts exceeding the levels established by the FDA. Learn more about the Amneal Pharmaceuticals nizatidine oral solution recall

    Avet Pharmaceuticals Tetracycline HCl Capsules

    Avet Pharmaceuticals is initiating a voluntary recall of the eight lots of tetracycline HCl capsules USP, 250mg and 500mg, 100-count bottles, to the consumer/user level. The voluntary recall is being initiated due to low out of specification dissolution test results. The recalled lots were distributed to wholesalers and distributors Nationwide between August 2019 and March 2020. Learn more about the Avet Pharmaceuticals tetracycline HCl capsules recall

    B. Braun Medical Ceftazidime and Dextrose in Duplex Container

    B. Braun Medical is voluntarily recalling one lot (batch H8J812) of 2g ceftazidime for injection USP and dextrose for injection USP (50mL) in Duplex container to the hospital/user level. During stability testing of batch H8J812, test results were found to exceed the specification limits for high molecular weight polymers at the 19-month (82-week) stability interval. Learn more about the B. Braun Medical ceftazidime and dextrose in Duplex container recall

    Fresenius Kabi Ketorolac Tromethamine Injection

    Fresenius Kabi is voluntarily recalling 13 lots of ketorolac tromethamine injection, USP, 30mg/mL, 1mL fill in a 2 mL amber vial and ketorolac tromethamine injection, USP, 60mg/2mL (30mg/mL), 2mL fill in a 2mL amber vial to the user level, due to the presence of particulate matter composed of the following elements: carbon, silicon, oxygen, and polyamides. Particulate matter was found in eight reserve sample vials. Learn more about the Fresenius Kabi ketorolac tromethamine injection recall

    GSK Consumer Healthcare Benefiber

    GSK Consumer Healthcare is voluntarily recalling five lots of Benefiber Healthy Shape Prebiotic Fiber Supplement powder and Benefiber Prebiotic Fiber Supplement powder due to the potential for green plastic pieces or shavings from bottle caps to be present in the product. There is a potential risk of choking or physical injury to the soft tissues of the mouth or gastrointestinal tract of a consumer using the product who may not see a broken piece or shaving of plastic cap. Learn more about the GSK Consumer Healthcare Benefiber recall

    ICU Medical Lactated Ringer's Injection

    ICU Medical, Inc. is voluntarily recalling one single lot of lactated ringer's injection, USP. The products are being recalled to the hospital/user level due to the presence of particulate matter identified as iron oxide. ICU Medical became aware of this issue through a single customer complaint. Administration of a drug product that contains metal particulate matter could result in adverse events ranging from inflammation at the site of injection to more serious events that could include the formation of a blood clot obstructing the flow of blood which could lead to end-organ damage or death. Learn more about the ICU Medical lactated ringer's injection recall

    International Laboratories Clopidogrel Tablets

    International Laboratories is voluntarily recalling Lot# 117099A of clopidogrel tablets, USP 75mg, packaged in bottles of 30 tablets, due to mislabeling. The product is labeled as clopidogrel tablets USP 75mg but may contain clopidogrel 75mg or simvastatin tablets USP 10mg. International Laboratories reports that no complaints have yet been received related to this event detailing medical illnesses or harmful effects. Learn more about the International Laboratories clopidogrel tablets recall

    QuVa Pharma R.E.C.K.

    QuVa Pharma is voluntarily recalling all lots of R.E.C.K. (ropivacaine, epinephrine, clonidine, ketorolac) 50mL in sodium chloride-60mL BD syringe that were prepared using sterile ketorolac being recalled by Fresenius Kabi. Fresenius Kabi recalled multiple lots of ketorolac on April 20, 2020 due to the presence of particulate matter found in the reserve sample vials. Learn more about the QuVa Pharma R.E.C.K. recall

    FDA Alerts

    Hydroxychloroquine and Chloroquine Not for Treatment of COVID-19 Outside Hospital Setting or Clinical Trial

    The FDA is concerned that hydroxychloroquine and chloroquine are being used inappropriately to treat non-hospitalized patients for COVID-19 or to prevent that disease. The FDA is aware of reports of serious heart rhythm problems in patients with COVID-19 treated with hydroxychloroquine or chloroquine, often in combination with azithromycin and other QT-prolonging medicines. They are also aware of increased use of these medicines through outpatient prescriptions. These risks, which are in the drug labels for their approved uses, may be mitigated when healthcare professionals closely screen and supervise these patients, such as in a hospital setting or a clinical trial. Therefore, they would like to remind healthcare professionals and patients of the known risks associated with both hydroxychloroquine and chloroquine. Their temporary use is authorized only in hospitalized patients with COVID-19 when clinical trials are not available, or participation is not feasible, through an Emergency Use Authorization. Learn more about the warning not to use hydroxychloroquine and chloroquine for treatment of COVID-19 outside hospital setting or clinical trial

    Ivermectin Not for Use in Humans as Treatment for COVID-19

    The FDA’s Center for Veterinary Medicine has recently become aware of increased public visibility of the antiparasitic drug ivermectin after the announcement of a research article that described the effect of ivermectin on SARS-CoV-2 in a laboratory setting. The Antiviral Research pre-publication paper, “The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro,” documents how SARS-CoV-2 (the virus that causes COVID-19) responded to ivermectin when exposed in a petri dish. Ivermectin is FDA-approved for use in animals for prevention of heartworm disease in some small animal species, and for treatment of certain internal and external parasites in various animal species. Learn more about the warning not to use ivermectin in humans as a treatment for COVID-19

    Remdesivir for Treatment of COVID-19

    The FDA issued an emergency use authorization for the investigational antiviral drug remdesivir for the treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalized with severe disease. While there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients. Learn more about remdesivir for treatment of COVID-19