OTC birth control pill, naloxone gain approval

Recalls and warnings

A class I recall of all Impella Left Sided Blood Pumps by Abiomed due to the risk of motor damage after contact with the distal stent in a transcatheter aortic valve replacement (TAVR). There have been reports of 26 injuries and four deaths related to this issue. The recall includes 7,895 devices distributed since May 1, 2021, and is a voluntary correction, not a product removal. Clinicians may continue to use the devices, keeping additional instructions for patients with TAVR in mind.

A class I recall of the ARROW Endurance Extended Dwell Peripheral Catheter System by Teleflex and its subsidiary Arrow International due to a risk of catheter separation and leakage. There have been reports of 18 injuries related to this issue, with no deaths. The recall includes 262,016 devices distributed from Oct. 26, 2018, to May 10, 2023.

A class I recall of the Amplatzer Steerable Delivery Sheath by Abbott due to an increased risk of air embolism. There have been reports of 16 injuries related to this issue, with no deaths. The recall includes 672 devices distributed from Oct. 4, 2022, to Feb. 22, 2023.

A class I recall of all Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators that were manufactured after 2017 and have a glassed feedthrough by Medtronic due to a risk of low or no energy output during high-voltage therapy. There have been reports of 22 injuries related to this issue, with no deaths. The recall includes 348,616 devices distributed from Oct. 13, 2017, to June 9, 2023.

A class I recall of Oxylog 3000 Plus Emergency and Transport Ventilators by Draeger Medical due to reports that the device stopped ventilation because of a depleted battery, even after being reconnected to AC power. There have been no injuries or deaths related to this issue. The recall includes 300 devices distributed from April 30, 2012, to June 13, 2022.

A class I recall of MEGA 2000 and MEGA SOFT Reusable Patient Return Electrodes by Megadyne due to a risk of serious burn injuries to patients. There have been reports of 63 injuries related to this issue, with no deaths. The recall includes 21,200 devices distributed from March 11, 2021, to May 9, 2023, and is a voluntary correction, not a product removal.

A class I recall of malfunctioning TruSignal SpO2 Sensors by GE HealthCare due to issues that may reduce defibrillation energy, expose patients to unintended voltage from other power sources, or give inaccurate readings. No related injuries or deaths have been reported. The recall includes 7,559 devices distributed from Jan. 1, 2021, to May 4, 2023.

A recall of six batches of albuterol sulfate inhalation aerosol (90 mcg) by Cipla due to the potential for leakage through the inhaler valve. No related adverse events have been reported.

A recall of one lot of dronabinol capsules USP and ziprasidone hydrochloride capsules (2.5 mg and 20 mg, respectively) by Major Pharmaceuticals and Rugby Laboratories due to a label mix-up. No related adverse events have been reported.

A letter to clinicians warning them to stop using the Quidel Triage Cardiac Panel. The manufacturer had previously recalled certain lots of the test after receiving reports that they provided inaccurate, lower-than-expected troponin levels in samples. Limited unaffected lots are available for distribution, and the manufacturer is prioritizing resupplying customers with no alternative testing methods available, the FDA said. The agency recommended that clinicians, laboratory personnel, and facilities consider alternative products or testing sites.

A safety communication warning consumers not to use ultrasound medical devices manufactured and distributed by RoyalVibe Health, CellQuicken, and Well-Being Reality. These devices have not been reviewed by the FDA, and their safety and effectiveness have not been established to diagnose, treat, or cure medical conditions.

Miscellaneous

A letter providing clinicians with updated information about paclitaxel-coated devices used to treat patients with peripheral arterial disease. After reviewing the available data, the FDA determined that they do not support an excess mortality risk for patients with paclitaxel-coated devices.

A letter recommending that clinicians and health care facilities implement conservation strategies for nonsterile, single-use pneumatic tourniquet cuffs in the U.S. The devices are used primarily in elective limb surgeries and in emergency and trauma settings. The FDA provided a list of best practices and instructions for cleaning and sterilization/disinfection of these devices, as well as recommended the use of alternative devices while localized supply constraints continue.

Approvals

Norgestrel (Opill) tablets for nonprescription use to prevent pregnancy. The birth control pill is the first daily oral contraceptive approved for use in the U.S. without a prescription. Contraceptive efficacy was established with the original approval for prescription use of norgestrel in 1973. Studies showed that consumer understanding of information on the label was high overall and that a high proportion understood the label instructions, supporting their ability to properly use the drug when it is available over the counter. The most common side effects include irregular bleeding, headaches, dizziness, nausea, increased appetite, abdominal pain, cramps, and bloating. The drug should not be used with another hormonal birth control product or by those who have or have ever had breast cancer. Patients who have any other form of cancer should ask a physician before use.

Traditional approval of lecanemab-irmb (Leqembi) to treat adult patients with Alzheimer's disease. The amyloid beta-directed antibody works by reducing amyloid plaques in the brain. The FDA converted the medication's approval from accelerated approval, which it received this past January with a postmarketing requirement to conduct a clinical trial, to traditional approval after deciding that the confirmatory study verified clinical benefit. Compared to placebo, the drug showed a statistically significant and clinically meaningful reduction in decline on the Clinical Dementia Rating Scale Sum of Boxes score in the 18-month randomized trial.

RiVive, the second over-the-counter naloxone nasal spray product approved by the FDA. The 3-mg spray is indicated for the emergency treatment of individuals with known or suspected opioid overdose. Approval for nonprescription use was supported by data from one study, which showed similar levels of the drug reach the bloodstream as those of an approved prescription naloxone product. Use may result in severe opioid withdrawal in those who are dependent on opioids.

Quizartinib (Vanflyta) to treat certain patients with acute myeloid leukemia. The drug is indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation and as maintenance monotherapy following consolidation chemotherapy to treat adult patients with newly diagnosed acute myeloid leukemia that is FLT3 internal tandem duplication-positive, as detected by an FDA-approved test. A boxed warning notes QT prolongation, torsades de pointes, and cardiac arrest. The drug is available only through a restricted program under a Risk Evaluation and Mitigation Strategy.

Talazoparib with enzalutamide to treat certain adult patients with prostate cancer. The drug in indicated in those with homologous recombination repair gene-mutated metastatic castration-resistant prostate cancer (mCRPC). The approval marks the first of this class of drugs for patients without prior treatment for mCRPC with mutations in genes other than BRCA and was based on a 55% reduction in the risk of radiographic progression-free survival compared to placebo. Efficacy was greater in those with BRCA mutations (80% risk reduction). Study participants reported anemia, neutropenia, and thrombocytopenia, with 39% requiring a red blood cell transfusion, including 22% who required multiple transfusions.

Marketing of the BT-001, a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy (CBT) to adult patients with type 2 diabetes. BT-001 provides CBT to help patients who are under the care of a clinician to better adhere to behaviors that help manage diabetes. It should be used adjunctively with standard of care.

Marketing of the Total-Tau Cerebral Spinal Fluid (CSF) and Elecsys β-Amyloid (1-42) CSF II tests for the detection of amyloid plaques in patients ages 55 years and older being evaluated for Alzheimer's disease. The test is intended to be used in conjunction with other clinical diagnostic assessments to help clinicians determine whether a patient has Alzheimer's disease. A positive test result does not establish a diagnosis of Alzheimer's disease or other cognitive disorder; however, a negative result reduces the likelihood that cognitive impairment is due to the disease.

An expanded indication for the ThermoCool SmartTouch Catheter to add the treatment of symptomatic persistent atrial fibrillation in drug-refractory patients. The clinical evidence used to support the expansion of indications was gathered from electronic health records of two hospital systems.

Marketing of Eroxon (MED3000), a nonmedicated hydro-alcoholic gel indicated for treatment of erectile dysfunction in adult males ages 22 years and older. The product is the first over-the-counter gel intended to treat erectile dysfunction. Its volatile components (alcohol and water) evaporate upon application to create a rapid, localized cooling effect on the glans penis, followed by a slower warming effect. This process stimulates the nerve endings, leading to tumescence and erection.

An expanded indication for the Inspire Upper Airway Stimulation System to include an updated apnea-hypopnea index (AHI) and body mass index (BMI) threshold. Available safety and effectiveness data increased the AHI baseline to 100 and BMI level to 40 kg/m² for adult patients with moderate to severe obstructive sleep apnea.

The FIX8 Laparoscopic Hernia Mesh Fixation (HMF) Device and Precision Open HMF Device for the fixation of prosthetic polypropylene or polyester mesh in laparoscopic and open surgical repair of femoral and inguinal hernias. The devices are comprised of an adhesive preloaded into a single-use handheld applicator and include a first-of-its-kind use of an acrylic glue to secure the mesh.

Cyfendus, a vaccine for postexposure prophylaxis of disease following suspected or confirmed exposure to Bacillus anthracis (anthrax). The vaccine is indicated in patients ages 18 through 65 years when administered in conjunction with recommended antibacterial drugs.

Marketing of the Duo UL, a high-level disinfectant foam for reprocessing ultrasound probes. It is intended for use by qualified health care personnel, contains chlorine dioxide, and is manually spread on the probes for a required two-minute contact time.

The TOPS System as an alternative to spinal fusion for the treatment of certain patients with degenerative spondylolisthesis with moderate to severe lumbar spinal stenosis. The implant attaches to the spine and, unlike a spinal fusion procedure, is designed to allow motion in the lumbar spine and may also help reduce pain and allow patients to return to normal activities.

Accelerated approval of glofitamab-gxbm (Columvi) to treat certain patients with large B-cell lymphoma. The drug is indicated in those with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after two or more lines of systemic therapy. A boxed warning cautions about serious or fatal cytokine release syndrome, and other warnings and precautions include neurologic toxicity (including immune effector cell-associated neurotoxicity), serious infections, and tumor flare. The drug should be administered only by a health care professional with appropriate medical support to manage severe reactions, including cytokine release syndrome.

First-time generic drug approvals

Loteprednol etabonate ophthalmic suspension (0.2%) for the temporary relief of the signs and symptoms of seasonal allergic conjunctivitis. (Brand name: Alrex)

Obeticholic acid tablets (5 mg and 10 mg) to treat adult patients with primary biliary cholangitis. (Brand name: Ocaliva)

Budesonide rectal foam (2 mg/dose) for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40 cm from the anal verge. (Brand name: Uceris)

Estradiol transdermal system USP (0.014 mg/d) for the prevention of postmenopausal osteoporosis. (Brand name: Menostar)

Diazepam rectal gel rectal delivery system (10 mg and 20 mg) for the management of selected, refractory patients with epilepsy who are on stable regimens of antiepileptic drugs and require intermittent use of diazepam to control bouts of increased seizure activity. (Brand name: Diastat AcuDial)

Midazolam in 0.9% sodium chloride injection (50 mg/50 mL [1 mg/mL] and 100 mg/100 mL [1 mg/mL] in single-dose bags) for continuous IV infusion to sedate intubated and mechanically ventilated adult, pediatric, and neonatal patients as a component of anesthesia or during treatment in a critical care setting. (Brand name: None provided)

Methsuximide capsules USP (300 mg) for the control of absence (petit mal) seizures that are refractory to other drugs. (Brand name: Celontin)

Edetate calcium disodium injection USP (1,000 mg/5 mL [200 mg/mL] in single-dose vials) for the reduction of blood levels and depot stores of lead in lead poisoning (acute and chronic) and lead encephalopathy in both pediatric and adult populations. (Brand name: Calcium Disodium Versenate)

Thalidomide capsules USP (50 mg, 100 mg, 150 mg, and 200 mg) to treat patients with newly diagnosed multiple myeloma, for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL), and as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (Brand name: Thalomid)

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