DRUG INFORMATION HAPPENINGS & HIGHLIGHTS

• An EUA has been issued for the “Lucira™ COVID-19 & Flu Home Test,” the first OTC at-home diagnostic test that detects both influenza and SARS-CoV-2 viruses. The single-use test kit analyzes a nasal swab sample in approximately 30 minutes. Samples can be selfcollected by individuals ≥ 14 years of age or collected by an adult for children ≥ 2 years of age.

• Global Pharma has issued a voluntary recall of all lots within expiry of OTC Artificial Tears lubricant eye drops, distributed by Ezricare and Delsam Pharma to the consumer level due to possible contamination. To date, there have been 55 reports of adverse events, including eye infections, permanent vision loss, and a death with a bloodstream infection, that are potentially associated with use of the product.

• The FDA has approved a 320 mg tablet of sotorasib (Lumakras®) in addition to the currently approved 120 mg strength tablet. Sotorasib is indicated for adults with KRAS G12C-mutated locally advanced or metastatic NSCLC after ≥ 1 prior systemic therapy.

• IBSA Pharma has initiated a voluntary recall of 27 lots of levothyroxine (Tirosint ®-Sol) oral solution to the consumer level due to product subpotency. Levothyroxine is indicated as a replacement therapy in hypothyroidism and in the management of thyrotropindependent thyroid cancer.

• Tezepelumab-ekko (Tezspire®) can now be administered by a patient or caregiver following FDA approval of a prefilled, fixed-dose, single-use, 210 mg/1.91 mL autoinjector pen. The product is also already approved in a prefilled syringe and vial for administration by an HCP. It is indicated as add-on maintenance treatment for patients ≥ 12 years old with severe asthma.

• Sanofi’s lixisenatide (Adlyxin®) has been permanently discontinued ; product will expire September 30, 2023. Lixisenatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2DM.

Drug Information Happenings

• The American Academy of Dermatology (AAD) has released updated guidelines for the treatment of atopic dermatitis with topical therapies in adults.

• The American College of Physicians (ACP) has updated its living clinical guideline on treatment of adults in the acute phase of major depressive disorder.

• The ICER released its final evidence report on oral therapies and monoclonal antibodies for multiple sclerosis.

• The ICER published its final evidence report on fezolinetant (investigational) for vasomotor symptoms (VMS) associated with menopause.

• The US Department of Health and Human Services (HHS) has announced that the mpox Public Health Emergency has ended, effective January 31, 2023.

• The VRBPAC met on February 28, 2023 to make recommendations on the safety and efficacy of Pfizer’s investigational respiratory syncytial virus (RSV) vaccine, seeking an indication for active immunization for the prevention of acute respiratory disease and lower respiratory tract disease (LRTD) caused by RSV in adults ≥ 60 years of age. The panel also met on March 1, 2023 to make recommendations on the safety and efficacy of GlaxoSmithKline’s pipeline RSV vaccine, seeking an indication for active immunization for the prevention of LRTD caused by RSV-A and RSV-B subtypes in adults ≥ 60 years of age.