A class I recall of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) and Cardiosave Rescue IABP by Datascope/Getinge because a burst, leaking, or torn intra-aortic balloon can cause blood to enter the IABP during therapy. There have been 134 related complaints, including 12 device shutdowns and five adverse events (four serious injuries and one death). The recall includes 4,454 devices distributed since March 6, 2012.
A class I recall of Mahurkar Acute Dual Lumen High Flow (13.5 French) Hemodialysis Catheters by Medtronic due to a potential hub defect that may cause leaks across the catheter's tubes. There have been two related injuries and no reported deaths. The recall includes 22,763 devices distributed from March 19 to Sept. 2, 2022.
A class I recall of the LifeSPARC Controller, part of the LifeSPARC System, by LivaNova (TandemLife) due to a software update being available to address the previous software malfunction that may erroneously detect frozen or unresponsive software and trigger the device to enter Critical Failure mode. There have been two related injuries and no reported deaths. The recall includes 589 devices distributed from Dec. 19, 2019, to Nov. 17, 2022.
A class I recall of certain Reactive Skin Decontamination Lotion (RSDL) kits by Emergent due to leak potential. The kits are carried by members of the military and are intended to remove and/or neutralize chemical warfare agents and T-2 Toxin from the skin. There have been three related complaints and no reported injuries or deaths. The recall includes 3,500 kits distributed from Oct. 4 to 14, 2022.
A recall of three lots of epinephrine (L-adrenaline) USP bulk active pharmaceutical ingredient by Spectrum Laboratory Products Inc., due to product discoloration. No related adverse events have been reported. Recalled products were distributed in the U.S. and Canada.
Draft recommendations proposing individual risk assessment for blood donations. The new proposed guidance would eliminate the time-based deferrals for men who have sex with men (and their female partners). Under the proposed guidance, the current donor history questionnaire would be revised to ask all prospective donors about new or multiple sexual partners in the past three months. All prospective donors who report having a new sexual partner or more than one sexual partner and who had anal sex in the past three months would be deferred from donation. The proposal includes no change in the donor deferral time periods for other HIV risk factors, including a history of nonprescription injection drug use or exchanging sex for money or drugs. Any individual who has ever had a positive test for HIV or who has taken any medication to treat HIV infection would continue to be deferred permanently. In addition, blood establishments would still be required to test all blood donations for evidence of certain transfusion-transmitted infections, including HIV, hepatitis B, and hepatitis C.
An urgent medical device correction letter about two potential issues with CADD Infusion System Infusion Sets for use with CADD pumps by Smiths Medical. The first issue may result in underdelivery or nondelivery of medication, despite the pump displaying that the infusion is running properly. The second issue, false “no disposable attached” alarms, is specific to CADD-Legacy pumps, which were discontinued on Dec. 31, 2022. The letter detailed the required steps to perform and specific instructions for treatment of patients requiring life-sustaining therapy.
Exploration of potential regulatory pathways for cannabidiol (CBD) products. The FDA concluded that a new regulatory pathway for CBD is needed that balances individuals' desire for access to CBD products with the regulatory oversight needed to manage risks. A new regulatory pathway would provide safeguards and oversight to manage and minimize risks related to CBD products, with potential risk management tools including clear labels, prevention of contaminants, CBD content limits, and measures to mitigate risk of ingestion by children, such as a minimum purchase age. A new pathway could also provide access to and oversight for certain CBD-containing products for animals. The agency also denied three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The FDA said it has not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm; therefore, it does not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.
Albuterol and budesonide (Airsupra) inhalation aerosol for as-needed treatment or prevention of bronchoconstriction and to reduce the risk of asthma attacks in adult patients with asthma. The drug is the first combination of an inhaled corticosteroid and a short-acting beta-agonist to be approved in the U.S. It is also the first product containing an inhaled corticosteroid to be approved in the U.S. as a reliever treatment, rather than as a controller, for asthma. The treatment helps relax the muscles and decrease inflammation in the lung airways to reduce the risk of severe asthma attacks. The most common side effects include headache, oral candidiasis, cough, and difficulty speaking.
Marketing of the Tidepool Loop, a mobile application intended for use with compatible devices for automated insulin dosing to help manage type 1 diabetes in persons ages 6 years and older. The app is a prescription-only device for single-patient use that works with integrated continuous glucose monitors (CGMs) and alternate controller-enabled pumps to automatically increase, decrease, and suspend delivery of basal insulin based on CGM readings and predicted glucose values. The app can also recommend and, with the user's confirmation, control the delivery of correction insulin amounts when glucose values are predicted to exceed user-configurable thresholds. The algorithm technology is designed to be compatible with other individual interoperable devices that meet prespecified acceptance criteria.
First-time generic approvals
Penciclovir cream (1%) for the treatment of recurrent herpes labialis (cold sores) in adults and pediatric patients ages 12 years and older. (Brand name: Denavir)
Vancomycin hydrochloride for oral solution USP (25 mg/mL and 50 mg/mL) for the treatment of Clostridioides difficile-associated diarrhea and enterocolitis caused by Staphylococcus aureus in adults and pediatric patients younger than 18 years of age. (Brand name: Firvanq Kit)
Selexipag tablets (200 µg, 400 µg, 600 µg, 800 µg, 1,000 µg, 1,200 µg, 1,400 µg, and 1,600 µg) to treat pulmonary arterial hypertension (PAH; World Health Organization Group I) to delay disease progression and reduce the risk of PAH hospitalization. (Brand name: Uptravi)
Bendamustine hydrochloride for injection USP (25 mg/vial and 100 mg/vial in single-dose vials) to treat chronic lymphocytic leukemia and indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. (Brand name: Treanda)
Dichlorphenamide tablets USP (50 mg) to treat primary hyperkalemic periodic paralysis, primary hypokalemic periodic paralysis, and related variants. (Brand name: Keveyis)
Gadobutrol injection (2 mmol/2 mL [1 mmol/mL], 7.5 mmol/7.5 mL [1 mmol/mL], 10 mmol/10 mL [1 mmol/mL], and 15 mmol/15 mL [1 mmol/mL] in single-dose vials) for use with magnetic resonance imaging as a gadolinium-based contrast agent. (Brand name: Gadavist)
Note: The FDA states that drugs are not always commercially available immediately after approval.