New COVID-19 boosters, DNA test for cancer risk OK’ed

Recalls and warnings

A recall of one lot of digoxin tablets USP, 0.125 mg, and one lot of digoxin tablets USP, 0.25 mg, by Marlex Pharmaceuticals, Inc. because the labels were reversed. The 0.125-mg tablets are yellow and say “201” on one side, while the 0.25-mg tablets are white to off-white and say “202” on one side. The mix-up in labels could cause either overdosing or underdosing.

A recall of two lots of Brexafemme (ibrexafungerp) tablets by Scynexis due to potential for cross-contamination with a nonantibacterial beta-lactam drug substance. The affected lots (LF21000008 and LF22000051) were distributed nationwide to wholesalers. The potential cross-contamination could lead to hypersensitivity reactions such as swelling, rash, urticaria, and anaphylaxis. No related adverse events have been reported.

A class I recall of Hamilton C1, C2, C3, and T1 ventilators based on reports of software issues that may cause the ventilators to stop without notice. The ventilator will switch to “ambient state” if the device is used for more than 91 days without a restart. There have been 80 reported complaints but no injuries or deaths related to this recall.

A class I recall of Abbott Proclaim and Infinity implantable pulse generators, used for nerve stimulation, due to complaints from patients that the devices will not exit MRI mode. This has occurred when the device's operating system or app was updated, among other instances.

A class I recall of one lot of Hudson RCI Addipak 0.9% full normal saline solution due to nonsterility. The affected lot passed sterility testing; however, another lot within the same cleaning cycle failed sterility testing, exposing the affected lot to potential contamination.

A class I recall of a one-way valve, 22F × 22M, by Mallinckrodt Manufacturing due to the devices not opening properly, preventing or reducing the flow of ventilated air or oxygen. This may cause serious adverse health consequences, including interruption in ventilation, potentially leading to insufficient oxygen in the blood resulting in respiratory failure and death. There have been two complaints and no reports of injuries or death.

A recall of one lot of Sandimmune (cyclosporine) oral solution, 100 mg/mL, by Novartis due to crystal formation observed in some bottles, which could potentially result in incorrect dosing. There is a reasonable probability that underdosing may result in lower exposures and decrease in efficacy, which could ultimately lead to graft rejection and graft loss in transplant patients, while overdosage may manifest as cyclosporine toxicity.

A recall of one lot of sucralfate oral suspension, 1 g/10 mL, by VistaPharm due to microbial contamination identified as Bacillus cereus.

Warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products to treat conditions such as conjunctivitis, cataracts, glaucoma, and others. Some of the FDA warning letters also cite the companies involved for quality issues related to product sterility, and some of these eye products are labeled as containing silver, which can cause some areas of the skin and other body tissues, including in the eye, to permanently turn gray or blue-gray.

A recall of three lots of 4.2% sodium bicarbonate injection and 1% and 2% lidocaine HCl injection, due to the potential for presence of glass particulate in vials.

A recall of all lots of ION Sinus Support, ION Biome Sinus, and Restore Sinus Spray products because FDA testing found microbial contamination identified as Microbacterium sp., Fictibacillus sp., Bacillus sp. (primarily B. malikii), and Paenibacillus sp. In the population most at risk, patients or individuals who recently underwent nasal or sinus surgery, there is a reasonable probability that the use of the affected product could potentially result in severe or life-threatening adverse events.

A recall of one lot of betaxolol tablets, USP 10 mg, as a precautionary measure due to a single oxycodone HCl tablet being found during the line clearance after the batch was packaged. The manufacturer has not received any reports of foreign tablets in any bottles of betaxolol, but there are only minor differences in appearance between the drugs and inadvertent exposure to this controlled substance could result in significant risks to certain patient populations.

Miscellaneous

A voluntary withdrawal of allergenic extract of pecan nut manufactured by ALK-Abelló due to reports of false-negative test results. One case of life-threatening anaphylaxis from subsequent pecan nut exposure was reported. Earlier in 2023, the FDA required that such products carry a warning about the risk of false-negative skin test results, recommending that clinicians consider confirming negative results with serologic testing or a medically supervised oral food challenge.

Updated labeling for temozolomide (Temodar) under Project Renewal, an initiative aimed at updating labeling information for older oncology drugs to ensure it is clinically meaningful and scientifically up to date.

Elimination of the Risk Evaluation and Mitigation Strategy (REMS) for alosetron hydrochloride (Lotronex and generics). Although the drug still carries safety risks, FDA has determined the REMS is no longer necessary to ensure the benefits outweigh the serious risks of ischemic colitis and serious complications of constipation.

Approvals

Approvals and authorizations of new formulations of the COVID-19 vaccines manufactured by Moderna, Pfizer, and Novavax. The new formulations have been updated to include a monovalent component that corresponds to the currently circulating omicron variant XBB.1.5. Individuals 5 years of age and older, regardless of previous vaccination, are now eligible to receive a single dose of an updated vaccine at least two months since the last dose of any COVID-19 vaccine. Children 6 months through 4 years of age who have previously been vaccinated against COVID-19 are eligible to receive one or two doses of an updated mRNA vaccine, depending on previous COVID-19 vaccination, while children who have not yet been vaccinated are eligible to receive three doses of the updated Pfizer-BioNTech vaccine or two doses of the updated Moderna vaccine.

Marketing authorization of the Invitae Common Hereditary Cancers Panel, an in vitro diagnostic test that can help detect genetic variants associated with an elevated risk of developing certain cancers. The test, the first of its kind to gain FDA marketing authorization, evaluates DNA extracted from a blood sample to identify variants in 47 genes. It requires a prescription; the specimen is then collected at the point of care and sent to a laboratory for testing. Some of the most clinically significant genes that the test identifies are BRCA1 and BRCA2, Lynch syndrome-associated genes (MLH1, MSH2, MSH6, PMS2, and EPCAM), CDH1 (mainly associated with hereditary diffuse gastric cancer and lobular breast cancer), and STK11 (associated with Peutz-Jeghers syndrome). The risks associated with the test are mainly the possibility of false-positive and false-negative test results, as well as possible misunderstanding of the results, the FDA said.

Approval of natalizumab-sztn (Tyruko), the first biosimilar to Tysabri injection for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko, like Tysabri, is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn's disease. Tyruko is approved to treat clinically isolated, relapsing-remitting, and active secondary progressive MS.

Approval of momelotinib (Ojjaara), a kinase inhibitor indicated for the treatment of intermediate or high-risk myelofibrosis, including primary or secondary cases (post-polycythemia vera and post-essential thrombocythemia), in adults with anemia. The most common adverse reactions were dizziness, fatigue, bacterial infection, hemorrhage, thrombocytopenia, diarrhea, and nausea.

Marketing authorization of the ensoETM, a multilumen silicon tube intended to be inserted into a patient's esophagus to control the patient's temperature and to reduce the likelihood of ablation-related esophageal injury during radiofrequency cardiac ablation. The device connects to external heat exchanger and cooling systems and is also intended to provide gastric decompression and suctioning.

Marketing authorization of the Esolution Esophageal Retractor from S4 Medical Corp., a catheter-based device intended to reduce the risk of injuries to the esophagus that may occur during an ablation procedure to treat atrial fibrillation. The device is inserted in a patient's mouth, into the esophagus, and uses mechanical force and vacuum suction to move the esophagus away from the source of ablation energy.

Marketing authorization of the Xenex Disinfection Services, Inc., LightStrike+ system, which emits ultraviolet germicidal light to reduce the number of microbes present on nonporous, noncritical medical device surfaces in the health care environment, after manual cleaning and disinfection. The system is intended for use in unoccupied rooms in clinical settings, such as operating rooms, patient examination rooms, or inpatient hospital rooms.

Marketing authorization for the 23andMe Personal Genome Service Genetic Health Risk Report for BRCA1/BRCA2. The direct-to-consumer test was updated to add 41 BRCA1/BRCA2 variants to the previously authorized test.

First-time generic drug approvals

Palbociclib, 75-mg, 100-mg, and 125-mg tablets, for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy, or fulvestrant in patients with disease progression following endocrine therapy (Brand name: Ibrance)

Lisdexamfetamine dimesylate, 10-mg, 20-mg, 30-mg, 40-mg, 50-mg, 60-mg, and 70-mg capsules, for the treatment of attention deficit hyperactivity disorder and moderate to severe binge eating disorder (Brand name: Vyvanse)

Tretinoin gel (microsphere), for the topical treatment of acne vulgaris (Brand name: Retin-A-Micro)

Calcium gluconate injection, 10,000 mg/100 mL (100 mg/mL), for the treatment of acute symptomatic hypocalcemia (No brand name provided)

Levonorgestrel and ethinyl estradiol and ferrous fumarate, 0.1 mg/0.02 mg and 75 mg tablets, for use by females of reproductive potential to prevent pregnancy (Brand name: Balcoltra)

Halobetasol propionate topical foam, 0.05%, for the topical treatment of plaque psoriasis (Brand name: Lexette)

Lifitegrast ophthalmic solution, 5%, for the treatment of the signs and symptoms of dry eye disease (Brand name: Xiidra)

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