Combined rapid flu, COVID-19 test approved

Recalls and warnings

A class I recall updating instructions for Boston Scientific's Obsidio conformable embolic due to a concern for risks with using this device anywhere in the gastrointestinal area. Use of this product with the aliquot technique or pushing with saline may cause off-target embolization and ischemia, including of the small bowel, which may lead to prolonged hospitalization, additional surgery such as bowel resection or diverting colostomy, or death. There have been 15 injuries and four deaths related to this issue.

A class I recall and updated instructions for Trilogy Evo, Trilogy EV300, Trilogy Evo O2, and Trilogy Evo Universal ventilators to resolve several previously reported safety issues that may affect the devices' ability to support patient breathing. There have been nine reported injuries and one reported death. Philips Respironics also issued additional instructions for Trilogy Evo Ventilators related to use of in-line nebulizers. The company has not received any specific complaints of device malfunctions resulting from in-line nebulizer use. An additional class I recall was issued for Trilogy Evo, Trilogy Evo O2, Trilogy EV300, Trilogy Evo Universal, Aeris EVO, Garbin Evo, and LifeVent EVO2 devices due to the risk of aerosol deposits accumulating over time on the device's internal flow sensor when in-line nebulizers are used in certain locations. There have been four reported injuries related to this issue.

A class I recall of VasoView HemoPro 1 and 1.5 endoscopic vessel harvesting systems by Getinge and Maquet Cardiovascular due to the risk that silicone may detach from the harvesting tool during use, causing silicone debris to enter the patient. This can render the device nonfunctional, requiring replacement. The use of affected product may cause serious adverse health consequences, including injury or blockage of blood vessels, infection, and death. There have been 17 reported injuries and no reports of death.

A class I recall notifying users of Medtronic's MiniMed 600 and 700 series insulin pumps of an increased risk for reduced battery life and less time until shutdown after a battery alert occurs. Pumps that have been dropped or bumped or that have experienced another physical impact may have damaged electrical components causing this issue. Even a single drop can impact battery life. From January 2023 to September 2024, Medtronic received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis related to this issue. There have been no reports of death.

A class I recall of specific lots of the BLUSelect, BLUgriggs, and BLUperc products by Smiths Medical due to a manufacturing defect that may cause the pilot balloon to disconnect from the tracheostomy inflation line. If the pilot balloon used to inflate the tracheostomy cuff disconnects, pressure may not be maintained, which can lead to inadequate ventilation and increased risk of aspiration. There have been 12 reported injuries and no reports of death.

A class I recall and updated instructions for the Phasitron 5 in-line valve by Sentec/Percussionaire due to an increase in reports of patient injuries after users failed to remove the blue plug from the expiratory port when applying therapy directly to a patient's airway. There have been six reported injuries and no reports of death. An additional class I recall of certain lots of Phasitron 5 breathing circuits by Percussionaire relates to the unexpected presence of nickel coating on one of the circuit's components. The use of affected products may cause serious adverse health consequences, including lung injury from inflammation, severe airway narrowing, lower immunity, allergic reactions, and death. There have been three reported injuries and no reports of death related to this issue.

A recall expansion of clonazepam orally disintegrating tablets USP by Endo due to potential product carton strength mislabeling. An ongoing investigation identified the possibility that the affected clonazepam product lot numbers contain a limited number of cartons printed with the incorrect strength and National Drug Code due to an error by a third-party packager. The blister strips and tablets inside the product pack reflect the correct strength for the lot. There have been no adverse events reported associated with the recall.

An alert to not use BioZorb markers and BioZorb LP markers by Hologic Inc. following a voluntary recall for removal of all lots of unused BioZorb markers. The recall is due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue.

Miscellaneous

A proposal to remove oral phenylephrine as an active ingredient that can be used in over-the-counter monograph drug products for the temporary relief of nasal congestion after an agency review of the available data determined that oral phenylephrine is not effective for this use. The proposed order is based on effectiveness concerns, not on safety concerns.

A new open access dataset generated in a clinical study that assessed the way people with Parkinson's disease move over time compared with those who don't have the disease. Researchers used wearable sensors and video cameras to gather data about study participants' gait. The resulting dataset can be used to assess the performance of algorithms used in wearable sensors and identify and validate digital biomarkers relevant to people with Parkinson's disease.

Approvals

Marketing authorization of the Healgen rapid check COVID-19/flu A&B antigen test, the first over-the-counter flu and COVID-19 combination test approved outside of emergency use authorizations. The nasal swab sample test detects proteins from both SARS-CoV-2 and influenza A and B and delivers results in approximately 15 minutes. Data from a study of individuals with signs and symptoms of COVID-19 and influenza showed that the test correctly identified 99% of negative and 92% of positive SARS-CoV-2 samples, 99.9% of negative flu A and B samples, and 92.5% and 90.5% of positive flu A and flu B samples, respectively.

Respiratory syncytial virus (RSV) vaccine (Abrysvo) for the prevention of lower respiratory tract disease caused by RSV in individuals 18 through 59 years of age who are at increased risk. The vaccine has been approved for this indication since 2023 for those 60 years of age and older and for pregnant individuals at 32 through 36 weeks' gestational age.

Marketing authorization and breakthrough device designation of the Ultromics Limited, EchoGo amyloidosis 1.0, an automated machine learning-based decision support system indicated as a screening tool to inform health care professionals of potential cardiac amyloidosis in patients over 65 years of age with heart failure undergoing routine cardiovascular assessment using echocardiography.

Revumenib (Revuforj), a menin inhibitor, for relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene (KMT2A) translocation in adult and pediatric patients ages one year and older. Efficacy was evaluated in a multicenter, single-arm trial in 104 adult and pediatric patients with relapsed or refractory acute leukemia with a KMT2A translocation. The complete remission plus partial hematologic recovery rate was 21.2%, with a median duration of 6.4 months. The most common adverse reactions were hemorrhage, nausea, and increased phosphate levels, among others. The treatment received an orphan drug designation.

Accelerated approval of eladocagene exuparvovec-tneq (Kebilidi), an adeno-associated virus vector-based gene therapy indicated for the treatment of adult and pediatric patients with aromatic L-amino acid decarboxylase (AADC) deficiency. The treatment received an orphan drug designation and is the first FDA-approved gene therapy for treatment of AADC deficiency. Safety and effectiveness were assessed in an open-label, single-arm clinical trial. Common adverse reactions include dyskinesia, fever, low blood pressure, and anemia, among others. The FDA also authorized the SmartFlow Neuro Cannula, an infusion tube inserted into a target in the brain to deliver eladocagene exuparvovec-tneq.

Accelerated approval of asciminib (Scemblix) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase. Efficacy was evaluated in a multicenter trial that randomized 405 patients to receive either asciminib or investigator-selected tyrosine kinase inhibitors (IS-TKIs). Major molecular response rate at 48 weeks was 68% in the asciminib arm and 49% in the IS-TKIs arm. Common adverse reactions included musculoskeletal pain, rash, fatigue, and upper respiratory tract infection. Asciminib was granted orphan drug designation.

Accelerated approval of zanidatamab-hrii (Ziihera) a bispecific HER2-directed antibody, for previously treated, unresectable or metastatic HER2-positive biliary tract cancer (BTC), as detected by an FDA-approved test. Efficacy was evaluated in a single-arm trial in 63 patients. Overall response rate was 52% and median duration of response was 14.9 months. Adverse reactions included diarrhea, infusion-related reactions, abdominal pain, and fatigue. The treatment carries a boxed warning for embryo-fetal toxicity. Approval was also granted to the Ventana Pathway anti-HER2/neu rabbit monoclonal primary antibody as a companion diagnostic device to aid in identifying patients with BTC who may be eligible for treatment with zanidatamab-hrii.

Marketing authorization of Valeda light delivery system from LumiThera, Inc., to help improve vision in certain dry age-related macular degeneration patients. Treatment with the device after approximately two years can provide an average improvement in vision equivalent to around one line on an eye chart.

First-time generic drug approvals

Drospirenone tablets, 4 mg, for use by females of reproductive potential to prevent pregnancy. (Brand name: Slynd)

Lofexidine tablets, 0.18 mg, for the mitigation of opioid withdrawal symptoms to facilitate abrupt opioid discontinuation in adults. (Brand name: Lucemyra)

Methylnaltrexone bromide injection, 8 mg/0.4 mL and 12 mg/0.6 mL, single-dose prefilled syringes, for the treatment of opioid-induced constipation (OIC) in adults with chronic noncancer pain and for the treatment of OIC in adults with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care. (Brand name: Relistor)

Nicardipine hydrochloride in 0.9% sodium chloride injection, 20 mg/200 mL (0.1 mg/mL), and 40 mg/200 mL (0.2 mg/mL), single-dose containers, for the short-term treatment of hypertension when oral therapy is not feasible.

Pantoprazole sodium for injection, 40 mg per vial (single-dose vial), for the short-term treatment (7 to 10 days) of gastroesophageal reflux disease associated with a history of erosive esophagitis and for the treatment of pathological hypersecretion conditions, including Zollinger-Ellison syndrome.

Prednisolone acetate ophthalmic suspension USP, 1%, to reduce the irritation, redness, burning, and swelling of eye inflammation caused by chemicals, heat, radiation, infection, allergy, or foreign bodies in the eye. (Brand name: Pred Forte)

Trametinib tablets, 0.5 mg and 2 mg, for the treatment of patients with melanoma with BRAF V600E or V600K mutations, patients with metastatic non-small-cell lung cancer with BRAF V600E mutation, patients with locally advanced or metastatic anaplastic thyroid cancer with BRAF V600E mutation, adult and pediatric patients 1 year of age and older with unresectable or metastatic solid tumors with BRAF V600E mutation, and pediatric patients 1 year of age and older with low-grade glioma with a BRAF V600E mutation. (Brand name: Mekinist)

Valbenazine capsules, 40 mg, 60 mg, and 80 mg, for the treatment of adults with tardive dyskinesia. (Brand name: Ingrezza)

Riluzole oral suspension, 50 mg/10 mL (5 mg/mL), for the treatment of amyotrophic lateral sclerosis. (Brand name: Tiglutik)

Amantadine extended-release capsules, 68.5 mg, for the treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications. (Brand name: Gocovri)

Dexmedetomidine injection USP, 400 mcg/4 mL (100 mcg/mL) and 1,000 mcg/10 mL (100 mcg/mL) multiple-dose vials, for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting and for the sedation of nonintubated patients prior to and/or during surgical and other procedures.

Note: The FDA states that drugs are not always commercially available immediately after approval.