A recall of all lots of metformin hydrochloride extended-release tablets USP (500 mg) by Apotex Corp due to the detection of N-nitrosodimethylamine (NDMA), a probable human carcinogen. Amneal Pharmaceuticals LLC also recalled all lots of metformin hydrochloride extended-release tablets (500 mg and 750 mg) due to detection of NDMA. Due to this issue, Marksans Pharma Limited, India, and Lupin Pharmaceuticals Inc. each recalled one lot of metformin hydrochloride extended-release tablets USP (500 mg), and Teva Pharmaceuticals USA Inc. recalled of 14 lots of metformin hydrochloride extended-release tablets USP (500 mg and 750 mg) distributed nationwide between Jan. 8, 2019, and May 27, 2020. The FDA said it will assess whether the recalls will result in shortages and will work with manufacturers to ensure appropriate testing while preventing or reducing any impact of shortages.
A recall of one lot of finasteride (1.25 mg) by MasterPharm LLC because the capsules have been found to contain undeclared minoxidil. The manufacturer has received 33 reports of increased heart rate, retention of water, dizziness, and low blood pressure. Recalled products were distributed nationwide on a patient-specific prescription basis.
A recall of 13 lots of thyroid tablets USP (NP Thyroid; 30 mg, 60 mg, and 90 mg) by Acella Pharmaceuticals LLC due to superpotency. The product may have up to 115% of the labeled amount of liothyronine (T3). There have been two reports of adverse events related to the recall. Affected products were distributed nationwide.
A class I recall of Python Embolectomy Catheters, Bard Embolectomy Catheters, and the OTW Latis Cleaning Catheters by Applied Medical due to risk of separation during use. There have been 46 complaints and three medical device reports regarding this issue but no reports of injury or death. A total of 19,400 recalled devices were distributed from Aug. 25, 2015, to March 1, 2019.
A class I recall of Langston Dual Lumen Catheters by Vascular Solutions Inc. due to risk of separation during use. There have been eight complaints and no reports of injury or death. A total of 4,304 recalled devices were distributed from July 12, 2019, to March 10, 2020.
A class I recall of the HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief by Medtronic due to risk of breaks and tears during setup. There have been 92 complaints related to the pre-implant pump assembly process, which includes both the strain relief screw breaking and outflow graft tears. A total of 4,924 recalled devices were distributed from March 1, 2018, to April 1, 2020.
A class I recall of the auto-registration feature of the StealthStation DBS Software by Medtronic due to inaccuracies caused by minor patient movements when used with NexFrame during a deep brain stimulation procedure. As of June, a total of 33 medical device reports were identified, 22 related to device malfunction and 11 related to injuries. Affected devices were distributed from Feb. 1, 2016, to May 1, 2019.
A recall of one lot of lactated Ringer's injection USP (1,000 mL) by ICU Medical Inc. due to the presence of particulate matter identified as iron oxide. Affected products were distributed nationwide.
An emergency use authorization for the investigational antiviral drug remdesivir. The authorization allowed the drug to be distributed in the U.S. and administered by clinicians, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in patients hospitalized with severe disease, defined as low blood oxygen levels or need for oxygen therapy or mechanical ventilation. Based on the evidence, the FDA determined that the known and potential benefits of the drug in treating severe COVID-19 currently outweigh its known and potential risks.
An alert that early data suggest potential inaccurate results from using the Abbott ID NOW point-of-care test to diagnose COVID-19. There have been 15 adverse event reports suggesting that some users are receiving inaccurate negative results. Any negative test results that are not consistent with a patient's clinical signs and symptoms or necessary for patient management should be confirmed with another test, the FDA said.
An emergency use authorization for the Everlywell COVID-19 Test Home Collection Kit, the first standalone at-home sample collection kit that can be used with certain authorized tests. The kit is authorized to be used by individuals at home who have been screened using an online questionnaire that is reviewed by a clinician. Such individuals can then self-collect a nasal sample at home using the kit. The FDA has also authorized two COVID-19 diagnostic tests, performed at specific laboratories, for use with samples collected using the kit.
An emergency use authorization for the first diagnostic test with the option of using home-collected saliva samples for COVID-19 testing. The Rutgers Clinical Genomics Laboratory's test uses samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.
An emergency use authorization for the Sherlock CRISPR SARS-CoV-2 Kit. The test, which looks for the specific target RNA or DNA sequences of the SARS-CoV-2 virus in upper respiratory specimens, is the first authorized use of CRISPR technology for an infectious disease test. Use is limited to laboratories certified to perform high-complexity tests.
An emergency use authorization for the CLEWICU system to be used by clinicians in the ICU as a diagnostic aid to assist with the early identification of adult patients who are likely to be diagnosed with respiratory failure or hemodynamic instability, which are common complications of COVID-19. The system provides continuous predictions based on data-driven algorithms and machine learning models, giving ICU clinicians the ability to view a patient's risk status from a remote location.
An emergency use authorization for the NASA VITAL (Ventilator Intervention Technology Accessible Locally). Developed by the National Aeronautics and Space Administration, the ventilator is intended to last three to four months and is specifically tailored for patients with COVID-19. It was added to the FDA's list of authorized ventilators and accessories under the ventilator emergency use authorization, which was issued in response to concerns about insufficient supply and availability of FDA-cleared ventilators during the pandemic. The device is built with components outside the current medical device supply chain and therefore does not impact the existing supply chain.
An emergency use authorization for infusion pumps and infusion pump accessories that meet certain safety, performance, and labeling criteria. The authorization is in response to concerns relating to the insufficient supply and availability of the devices for use by clinicians in the continuous infusion of medications, total parenteral nutrition, and/or other fluids into patients during the pandemic. This includes infusion pumps with remote monitoring or remote manual control features or administration sets.
An emergency use authorization for the Ascom teleCARE IP Nurse Call System to facilitate remote communication between patients and clinicians. The system is designed for use in health care environments, including temporary hospital facilities, and may reduce contact with patients who are in isolation rooms.
An emergency use authorization for the Eko ECG Low Ejection Fraction Tool. The tool is intended to be used by clinicians to assess left ventricular ejection fraction in adults with confirmed or suspected COVID-19 as a diagnostic aid to screen for potential cardiac complications associated with the disease or underlying cardiac conditions that may affect clinical management of the disease.
An emergency use authorization for the multiFiltrate PRO System and multiBic/multiPlus Solutions. The authorization is intended to help address shortages of continuous renal replacement therapy products during the pandemic.
An emergency use authorization for the Stryker Sustainability Solutions VHP N95 Respirator Decontamination System. The system uses vapor hydrogen peroxide to decontaminate compatible N95 respirators that may be contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse when there are insufficient supplies of face-filtering respirators due to the pandemic. N95s containing cellulose-based materials are incompatible with the system, and respirators are limited to a maximum of three decontaminations.
An emergency use authorization for the Duke Decontamination System. The system decontaminates compatible N95 or N95-equivalent respirators for reuse by health care personnel when there are insufficient supplies of these respirators resulting from the pandemic.
A letter to clinicians reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products STERRAD Sterilization Systems and to decontaminate only compatible N95 or N95-equivalent respirators for reuse during the COVID-19 pandemic. Using the correct decontamination cycle is necessary to avoid potentially compromising the performance, fit, and breathability of decontaminated N95 respirators
A letter to clinicians about the risk of health care facility staff who reprocess and sterilize medical devices to misinterpret the indicators used to validate the sterilization of medical devices. There is no standard indicator color to indicate a sterilized device. For example, the 3M Comply Hydrogen Peroxide Chemical Indicator 1248 uses blue to indicate an unprocessed device and pink to indicate a sterilized device, whereas the Aesculap MD334 Process Indicator Card uses the reverse. The FDA is collaborating with manufacturers of sterilization systems to improve product labeling and explore standardization for colors used to indicate sterilization.
An emergency use authorization for propofol (Propoven 2% emulsion) to maintain sedation via continuous infusion in patients ages 16 years or older who require mechanical ventilation in an ICU during the pandemic. The formulation is different than FDA-approved propofol drugs, which are in short supply due to the pandemic.
Abbreviated new drug applications for several drugs due to shortages or recent surges in demand: hydroxychloroquine sulfate tablets USP (200 mg), cisatracurium besylate injection USP (20 mg/10 mL), azithromycin tablets USP (600 mg), lidocaine hydrochloride injection USP (1%), dexmedetomidine hydrochloride (0.9% sodium chloride injection), and succinylcholine chloride injection USP (200 mg/10 mL).
Free access to the FDA MyStudies app. The app is now available to investigators as a platform to securely obtain patients' informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 control measures. The app is now referred to as COVID MyStudies in the Apple App Store and in the Google Play Store.
A new indication for dapagliflozin oral tablets (Farxiga) to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction. The drug is the first sodium-glucose cotransporter-2 inhibitor to be approved to treat adults with New York Heart Association functional class II to IV heart failure with reduced ejection fraction. Safety and effectiveness were evaluated in a randomized, double-blind trial of 4,744 participants. After 18 months, participants who received the drug had fewer cardiovascular deaths, hospitalizations for heart failure, and urgent heart failure visits than those who received placebo. The drug can cause dehydration, serious urinary tract infections, and genital yeast infections. Clinicians should assess volume status and kidney function in older patients, patients taking diuretics, and patients with kidney problems, low blood pressure, and signs and symptoms of metabolic acidosis or ketoacidosis. Serious cases of necrotizing fasciitis of the perineum (Fournier's gangrene) have been reported in people with diabetes taking the drug. The drug was already approved in addition to diet and exercise to improve glycemic control in adults with type 2 diabetes, as well as to reduce the risk of hospitalization for heart failure among adults with type 2 diabetes and known cardiovascular disease or other risk factors.
Flortaucipir F18 for IV injection (Tauvid) to help image tau pathology in patients being evaluated for Alzheimer's disease. The radioactive diagnostic agent is indicated for positron emission tomography imaging of the brain to estimate the density and distribution of aggregated tau neurofibrillary tangles, a primary marker of the disease. The agent's ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be lower in patients in earlier stages of cognitive decline. The most common adverse reactions were headache, injection site pain, and increased blood pressure.
Artesunate for injection to treat patients with severe malaria. The orphan drug is the only one approved in the U.S. to treat severe malaria since the marketing of quinine was discontinued by the manufacturer in March 2019. Treatment with IV artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen, the FDA said. In two randomized trials in Asia and Africa, the number of patients treated with artesunate who died in the hospital was significantly lower than the number of those treated with quinine. The most common adverse reactions were acute renal failure requiring dialysis, hemoglobinuria, and jaundice.
Capmatinib (Tabrecta) to treat adults with non-small-cell lung cancer that has spread to other parts of the body. The kinase inhibitor is the first therapy approved to treat this kind of cancer with mutations that lead to mesenchymal-epithelial transition exon 14 skipping. The FDA also approved a companion diagnostic, the FoundationOne CDx assay. In a trial of 28 patients who had never received treatment for non-small-cell lung cancer and 69 previously treated patients, the overall response rates to the orphan drug were 68% and 41%, respectively. Common side effects included peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite. Serious side effects include interstitial lung disease, hepatotoxicity, and pneumonitis.
Selpercatinib capsules (Retevmo) to treat patients with lung and thyroid cancers with a certain genetic alteration. The drug is approved to treat three types of tumors (non-small-cell lung cancer, medullary thyroid cancer, and other types of thyroid cancers) in patients whose tumors have a mutation or fusion in the rearranged during transfection (RET) gene. The kinase inhibitor is the first therapy approved specifically for cancer patients with the RET gene alterations. Approval was based on a trial of patients with each of the three types of tumors. The overall response rate ranged from 73% to 84%, with 58% to 75% of patients who responded to treatment having a response that lasted at least six months. The most common side effects include elevated liver enzymes, increased blood glucose levels, decreased white blood cell count, decreased albumin in the blood, decreased calcium in the blood, dry mouth, diarrhea, increased creatinine levels, increased alkaline phosphatase levels, hypertension, fatigue, swelling in the body or limbs, low blood platelet count, increased cholesterol levels, rash, constipation, and decreased sodium in the blood. The orphan drug can also cause serious side effects, such as hepatotoxicity, elevated blood pressure, QT prolongation, bleeding, and allergic reactions.
Ripretinib tablets (Qinlock) for the fourth-line treatment of adult patients with advanced gastrointestinal stromal tumors. The kinase inhibitor is indicated for those who have received prior treatment with three or more kinase inhibitor therapies, including imatinib. Approval was based on results of a randomized trial of 129 patients. Participants who received the drug had an average progression-free survival of 6.3 months, compared to one month among those who received placebo. The most common side effects were alopecia, fatigue, nausea, abdominal pain, constipation, myalgia, diarrhea, decreased appetite, palmar-plantar erythrodysesthesia syndrome, and vomiting. The orphan drug can cause serious side effects, including skin cancer, hypertension, and cardiac dysfunction manifested as ejection fraction decrease.
First-time generic approvals
Albuterol sulfate inhalation aerosol (90 µg [base]/actuation) for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in adults and children ages 4 years and older. (Brand name: Proventil HFA)
Epinephrine injection USP (30 mg/30 mL [1 mg/mL] in multiple-dose vials) for the emergency treatment of type I allergic reactions, including anaphylaxis, and to increase mean arterial blood pressure in adult patients with hypotension associated with septic shock. (Brand name: Adrenalin)
Buprenorphine transdermal system (5 µg/h, 7.5 µg/h, 10 µg/h, 15 µg/h, and 20 µg/h) for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. (Brand name: Butrans)
Clocortolone pivalate cream USP (0.1%) to treat the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. (Brand name: Cloderm)
Note: The FDA states that drugs are not always commercially available immediately after approval.