A class I recall of IMAGER II 5F Angiographic Catheters by Boston Scientific Corporation due to a potential for the catheter tip to become detached during a procedure or during procedure preparation. There are nine reported injuries related to this issue. The recall includes 6,130 devices distributed from July 16, 2018, to Nov. 26, 2019.
A class I recall of Over the Wire Embolectomy Catheters by LeMaitre Vascular Inc. due to a risk of the balloon catheter failing to deflate during use. The FDA has received 26 related medical device reports, with no deaths and one injury. The recall includes 49,393 devices distributed from Nov. 7, 2014, to March 5, 2020.
A recall of eight lots of tetracycline hydrochloride capsules USP (250 mg and 500 mg in 100-count bottles) by Avet Pharmaceuticals Inc. due to failed dissolution specification test results. Recalled products were distributed to wholesalers and distributors nationwide between August 2019 and March 2020.
A recall of three lots of nizatidine oral solution (15 mg/mL in 480-mL bottles) by Amneal Pharmaceuticals, LLC, due to potential N-nitrosodimethylamine (NDMA) amounts exceeding acceptable levels. NDMA is classified as a probable carcinogen. Affected lots were distributed directly to wholesalers, who further distributed them to retail pharmacies and consumers nationwide.
A recall of 13 lots of ketorolac tromethamine injection USP (30 mg/mL, 1-mL fill and 30 mg/mL, 2-mL fill in 2-mL amber vials) by Fresenius Kabi USA LLC due to the presence of particulate matter. The particulate matter, found in eight reserve sample vials, was composed of carbon, silicon, oxygen, and polyamides. Recalled lots were distributed nationwide between May 5, 2018, and Dec. 16, 2019. In response to the recall, QuVa Pharma Inc. recalled all lots of ropivacaine, epinephrine, clonidine, and ketorolac (50 mL in sodium chloride-60 mL BD syringes) that were prepared using sterile ketorolac being recalled by Fresenius Kabi.
A recall of one lot of ceftazidime for injection USP (2 g) and dextrose for injection USP (50 mL) by Braun Medical Inc. due to out-of-specification results for high-molecular-weight polymers. Affected products were distributed nationwide to domestic distributors.
A recall of one TRUE METRIX AIR Blood Glucose Meter by Trividia Health Inc. due to an incorrect factory-set unit of measure. The individual meter displayed glucose results in mmol/L rather than mg/dL and was distributed in the U.S. in February 2019.
Emergency use authorizations for 95 tests, including 12 antibody tests and one antigen test. As of May 13, more than 390 test developers have submitted or have said they will be submitting applications to make tests that detect the virus. In addition, more than 245 labs have notified the FDA that they have begun testing. To further expand testing options, the FDA said that spun synthetic swabs, with a design similar to Q-tips, could be used to test patients by collecting a sample from the front of the nose. U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills, developed a polyester-based Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing, with plans to produce large quantities.
An emergency use authorization for SARS-CoV-2 antibody tests. The “umbrella” authorization applies to tests that have been evaluated in an independent validation study performed at the NIH's National Cancer Institute or by another government agency designated by the FDA and which the agency confirms to meet certain criteria as part of the scope of authorization. Authorized devices are intended to help identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection, by detecting antibodies (IgG, IgG and IgM, or total) to the virus in human plasma and/or serum.
The first emergency use authorization for a COVID-19 antigen test. The Sofia 2 SARS Antigen FIA test by Quidel Corporation quickly detects fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs. The test can provide results in minutes. However, antigen tests may not detect all active infections and, while they are very specific for the virus, are not as sensitive as molecular polymerase chain reaction (PCR) tests. Negative results from an antigen test may need to be confirmed with a PCR test prior to making treatment decisions.
A letter to clinicians about the use of serological/antibody tests. The FDA recommended that clinicians continue to use serological tests intended to detect antibodies to SARS-CoV-2, as appropriate, to help identify people who may have been exposed to the virus or who have recovered from COVID-19. Clinicians should also be aware of the limitations of these tests and the risks to patients and the community if the test results are used as the sole basis to diagnose COVID-19, the FDA said. The agency is not aware of an antibody test that has been validated for diagnosis of COVID-19 and does not expect that one can be shown to definitely diagnose or exclude the infection.
A reissued emergency use authorization for the Laboratory Corporation of America COVID-19 RT-PCR Test to permit testing of samples collected by patients at home. The authorization allows testing of a sample collected from the patient's nose using the Pixel by LabCorp COVID-19 Test self-collection kit, which contains nasal swabs and saline. After patients self-swab to collect their nasal sample, they mail their sample in an insulated package to a LabCorp lab for testing.
An update on convalescent plasma as a potential treatment for COVID-19. The FDA is encouraging those who have recovered from COVID-19 to donate antibody-rich plasma to help develop blood-related therapies. The safety and efficacy of convalescent plasma is being evaluated in clinical trials and through expanded access of the potential therapy. The FDA has issued guidance providing recommendations to clinicians and investigators on the administration and study of convalescent plasma in patients currently seriously ill with COVID-19.
A drug safety communication regarding known side effects of hydroxychloroquine and chloroquine. Such side effects, including serious and potentially life-threatening heart rhythm problems, have been reported with their use for the treatment or prevention of COVID-19, for which they are not approved by the FDA. Clinicians can mitigate these risks, which are on the drug labels for their approved uses, by closely screening and supervising patients receiving the drugs off-label in the hospital or a clinical trial, as indicated in their emergency use authorization to treat COVID-19. In addition, due to a significant surge in demand for these drugs, the FDA is working with manufacturers to ramp up production safely and expeditiously. The agency also issued guidance to support generic development of these drugs.
Guidance on infusion pumps and accessories during the pandemic. The policy aims to help ensure the availability of infusion pumps and accessories for patients who require continuous infusion of medications, nutrition, and other fluids and help foster technologies, such as remote capabilities, that maintain a safer physical distance between clinicians and patients.
Emergency use authorizations for two blood purification systems to treat adults with confirmed COVID-19 admitted to the ICU with confirmed or imminent respiratory failure. The FDA issued an authorization to Terumo BCT Inc. and Marker Therapeutics AG for their Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices. It also authorized the Seraph 100 Microbind Affinity Blood Filter device by ExThera Medical Corporation.
An emergency use authorization for IntelliVue Patient Monitors MX750/MX850, the IntelliVue 4-Slot Module Rack FMX-4, and IntelliVue Active Displays AD75/AD85 by Philips Medizin Systeme Böblingen GmbH. The monitors, intended to be used by clinicians in the hospital for remote monitoring of patients who are or are suspected to have COVID-19, reduce the amount of clinician contact with patients who are in isolation rooms.
Emergency use authorizations for three decontamination systems for compatible N95 and N95-equivalent respirators. The Sterilucent HC 80TT Hydrogen Peroxide Sterilizer and Stryker Instruments' Sterizone VP4 Sterilizer1 N95 Respirator Decontamination Cycle were authorized to decontaminate compatible N95 or N95-equivalent respirators for single-user reuse during the pandemic. In addition, the STERIS V-PRO 1 Plus, maX, and maX2 Low Temperature Sterilization Systems using the STERIS N95 Decontamination Cycle (non-lumen cycle) were authorized for reuse by health care workers in hospital settings.
An emergency use authorization for the Perfusor Space Syringe Infusion Pump System, Infusomat Space Volumetric Infusion Pump System, and Outlook ES during the pandemic. The devices were authorized for use in the tracheal delivery of continuous nebulized medications into a nebulizer to treat patients of all ages with confirmed or suspected COVID-19. An authorization was also issued for ground medical transport use of the Infusomat Space Volumetric Infusion Pump System.
Guidance setting forth a temporary policy for outsourcing facilities to compound certain human drugs for hospitalized patients during the public health emergency. The policy aims to provide patient access to treatment options for COVID-19 when hospitals experience difficulties accessing certain FDA-approved drugs.
Guidance regarding a temporary policy for the repackaging or combining of FDA-approved propofol injectable emulsion (10 mg/mL) products to treat and manage hospitalized patients during the pandemic. The guidance provides regulatory flexibility for state-licensed pharmacies (including hospital pharmacies), federal facilities, and outsourcing facilities that repackage or combine FDA-approved propofol products for hospitals that are having difficulty obtaining adequate supplies of the FDA-approved version in the sizes they use to support or treat patients with COVID-19.
Guidance to help increase availability and capability of imaging systems needed for diagnosis and treatment monitoring of lung disease in patients during the pandemic. Such imaging products include medical X-ray, ultrasound, MRI systems, and image-analysis software used to diagnose and monitor medical conditions. Increasing the availability of mobile and portable imaging systems may increase options to image patients inside and outside of health care facilities, which could help reduce the spread of COVID-19, the FDA said.
Guidance outlining a temporary policy to help expand the availability of portable cryogenic oxygen and nitrogen containers. The demand for these critical medical gases is expected to rise during the pandemic and may result in a shortfall of portable cryogenic medical gas containers that meet regulatory requirements, the FDA said. The agency does not intend to take enforcement action against firms that fill and distribute oxygen and nitrogen in portable cryogenic medical gas containers that do not comply with certain regulatory requirements, provided that alternative, specific safeguards are in place to prevent gas mix-ups.
Development of reference sequence data for the SARS-CoV-2 reference strain in the U.S. Availability of traceable and quality-controlled data will help test developers and vaccine developers expedite development of medical countermeasures.
Guidance to help expand the availability of remote digital pathology devices during the pandemic. The policy aims to help expand the availability of devices for remote reviewing and reporting of scanned digital images of pathology slides, with the goal of facilitating continuity of patient care, preventing disruptions to critical pathology services, and reducing health care personnel contact and risk of exposure to the virus.
Guidance on digital health devices for treating psychiatric disorders during the pandemic. The policy aims to help expand the availability of computerized behavioral therapy devices and other digital health therapeutic devices for psychiatric disorders, as well as low-risk general wellness and digital health products for mental health or psychiatric conditions, while reducing patient-clinician contact.
A statement regarding efforts to increase availability of alcohol-based hand sanitizer. As a result of these efforts, more than 1,500 additional manufacturers have registered with the FDA to produce hand sanitizer. The agency also addressed safety concerns. In March, calls to the National Poison Data System related to hand sanitizer increased by 79% compared to March 2019, with the majority accounting for unintentional exposures in children ages 5 years and younger. The FDA underscored the importance of making hand sanitizer unpalatable to people, including children, through the use of denatured alcohol, and also warned about hand sanitizer sold with fraudulent claims. It has warned Prefense LLC for selling hand sanitizer products with misleading claims that the products are safe and/or effective for the prevention and treatment of COVID-19.
Results from two postapproval studies of liquid-filled intragastric balloon devices used for weight loss. The FDA in 2017 first communicated two specific risks for the Orbera and ReShape liquid-filled intragastric balloons: spontaneous hyperinflation and acute pancreatitis. In a letter to clinicians, the agency reported that postapproval studies found a small number of these events, whereas there were none reported in the studies used in their premarket approval applications. Selling and distribution of the ReShape device were stopped on Jan. 1, 2019, but the FDA will continue to work with Apollo Endosurgery, the manufacturer of the Orbera device, to ensure that the product labeling includes the postapproval study findings.
A request that manufacturers immediately withdraw all prescription and over-the-counter (OTC) ranitidine medications from the market due to potential contamination with NDMA. The call to action is the latest step in the FDA's ongoing investigation of NDMA in ranitidine, a histamine-2 receptor antagonist commonly known by the brand name Zantac. The impurity in some ranitidine products increases over time and when stored at higher than room temperatures, which may result in consumer exposure to unacceptable levels of NDMA. As a result of the immediate market withdrawal request, ranitidine products will not be available for new or existing prescriptions or OTC use in the U.S. FDA testing has not found NDMA in drugs approved for the same or similar uses, such as famotidine (Pepcid), cimetidine (Tagamet), esomeprazole (Nexium), lansoprazole (Prevacid), and omeprazole (Prilosec).
Coagulation factor VIIa (recombinant)-jncw (Sevenfact) to treat and control bleeding episodes occurring in patients ages 12 years and older with hemophilia A or B who have developed inhibitors. The drug is the first hemophilia treatment that contains an active ingredient obtained from rabbits genetically engineered to produce a protein necessary for blood coagulation. The active ingredient is a recombinant analog of human coagulation factor VII, which is expressed in the mammary gland of the rabbits and secreted into their milk. During purification and processing of the milk, the analog is converted into activated coagulation factor VIIa. The FDA's Center for Veterinary Medicine approved this process and determined it to be safe for the rabbits and their handlers and to have no significant impact on the environment. In a study of 27 patients with 465 mild or moderate and three severe bleeding episodes, either a low dose or higher dose of the drug successfully treated about 86% of bleeding events. The most common side effects are headache, dizziness, infusion site discomfort, infusion-related reaction, infusion-site hematoma, and fever. The drug is contraindicated in patients with known allergy or hypersensitivity to rabbits or rabbit proteins.
Mitomycin gel (Jelmyto) to treat low-grade upper-tract urothelial cancer. The orphan drug inhibits the transcription of DNA into RNA and is the first therapy approved specifically for patients with this type of cancer. In a trial of 71 patients, 58% had a complete response after six weekly treatments, and 46% of those maintained a complete response after 12 months. Common side effects include ureteric obstruction, flank pain, urinary tract infection, hematuria, renal dysfunction, fatigue, nausea, abdominal pain, dysuria, and vomiting. Serious side effects include ureteric obstruction, flank pain, and urosepsis. Patients with ureteric obstruction may require transient or long-term stents to relieve the obstruction, which may be persistent or fail to resolve completely.
Pemigatinib (Pemazyre) to treat adults with certain types of previously treated, locally advanced or metastatic cholangiocarcinoma. The orphan drug is the first therapy indicated for patients who have tumors that have a fusion or other rearrangement of a gene called fibroblast growth factor receptor 2. In a trial of 107 patients, the overall response rate to the drug was 36%, and among those who responded, 63% maintained their response for at least six months and 18% maintained their response for 12 months or more. The most common adverse reactions were hyperphosphatemia, hypophosphatemia, alopecia, diarrhea, nail toxicity, fatigue, dysgeusia, nausea, constipation, stomatitis, dry eye, dry mouth, decreased appetite, vomiting, joint pain, abdominal pain, back pain, and dry skin. Ocular toxicity is also a risk of the drug.
Sacituzumab govitecan-hziy (Trodelvy) to treat adults with metastatic triple-negative breast cancer. The Trop-2-directed antibody and topoisomerase inhibitor drug conjugate is indicated for patients who have received at least two prior therapies for metastatic disease. Approval was based on the results of a trial of 108 patients, where the drug was associated with an overall response rate of 33.3%, with a median duration of response of 7.7 months. Of the patients who responded to the drug, 55.6% maintained their response for at least six months, and 16.7% maintained their response for 12 months or more. A boxed warning advises about the risks of severe neutropenia and severe diarrhea. The most common side effects are nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, decreased appetite, rash, and abdominal pain.
Tucatinib (Tukysa) in combination with chemotherapy (trastuzumab and capecitabine) to treat adults with advanced forms of unresectable or metastatic HER2-positive breast cancer. The kinase inhibitor is indicated for patients who have received one or more prior treatments and is the first new drug approved as part of Project Orbis, an international collaboration. In a trial of 612 patients, the median progression-free survival in patients who received the orphan drug in combination with chemotherapy was 7.8 months, compared to 5.6 months in those who received placebo. Median overall survival was 21.9 months in the intervention group and 17.4 months in the placebo group. Common side effects include diarrhea, palmar-plantar erythrodysesthesia, nausea, fatigue, hepatotoxicity, vomiting, stomatitis, decreased appetite, abdominal pain, headache, anemia, and rash. Serious side effects include severe diarrhea associated with dehydration, acute kidney injury, and death.
First-time generic approvals
Metformin hydrochloride oral solution (500 mg/5 mL) for improving glycemic control in patients ages 10 years and older with type 2 diabetes. (Brand name: Riomet)
Esomeprazole magnesium delayed-release for oral suspension (10 mg, 20 mg, and 40 mg) for the treatment of gastroesophageal reflux disease, risk reduction of NSAID-associated gastric ulcer, Helicobacter pylori eradication to reduce the risk of duodenal ulcer recurrence, and pathological hypersecretory conditions. (Brand name: Nexium)
Prednisolone sodium phosphate oral solution (30 mg/5 mL) for the control of severe or incapacitating allergic conditions, including seasonal or perennial allergic rhinitis, asthma, contact dermatitis, atopic dermatitis, serum sickness, and drug hypersensitivity reactions. (Brand name: Orapred)
Thiotepa for injection USP (15 mg/vial and 100 mg/vial in single-dose vials) to treat adenocarcinoma of the breast or ovary; to control intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities; and to treat superficial papillary carcinoma of the urinary bladder. (Brand name: Tepadina)
Carfilzomib for injection (30 mg in single-dose vials) for the treatment of patients with relapsed or refractory multiple myeloma who have received one to three lines of therapy. (Brand name: Kyprolis)
Melphalan for injection (50 mg in single-dose vials) for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate. (Brand name: Evomela)
Note: The FDA states that drugs are not always commercially available immediately after approval.