7 Drugs Approved for Primary Care: Q3 2024

COVID-19 prevention: Updated 2024-2025 formulations of mRNA COVID-19 vaccines, that include a monovalent component corresponding to KP.2, a currently-circulating strain of the Omicron variant, were approved and granted emergency use authorization (EUA). The FDA awarded approval for Pfizer’s Comirnaty and Moderna’s Spikevax mRNA vaccines for individuals 12 years and older and granted EUA for both vaccines for individuals 6 months through 11 years. (Approved 8/22/24, Pfizer-BioNTech & Moderna)

The FDA also granted EUA for an updated version of the Novavax COVID-19 vaccine that targets the currently circulating Omicron variant JN.1 strain of SARS-CoV-2 for use in individuals aged 12 years and older who have never been vaccinated against COVID-19. (Approved 8/30/24, Novavax Inc.)

For Comirnaty package insert, please click here.

For Spikevax package insert, please click here.

For Novavax fact sheet, please click here.

Allergic reactions: Epinephrine nasal spray (neffy) 2 mg, is a novel alpha and beta-adrenergic receptor agonist indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adults and children who weight at least 66 pounds. It is the first and only needle-free treatment alternative to epinephrine injection. It is administered via single dose nasal spray into 1 nostril. A second dose may be administered in the same nostril with a new nasal spray starting 5 minutes after first dose in the absence of clinical improvement or if symptoms worsen after initial treatment. Absorption of neffy may be affected by underlying structural and anatomical nasal conditions, according to the prescribing information. (Approved 8/9/24, ARS Pharmaceuticals)

For full prescribing information, please click here.

Atopic dermatitis: Roflumilast (Zoryve) cream 0.15%, is a once-daily topical phosphodiesterase 4 inhibitor that received a supplemental new drug application approval for the treatment of mild-to-moderate atopic dermatitis in adults and children as young as age 6 years. (Approved 7/9/24, Arcutis Biotherapeutics)

For full prescribing information, please click here.

Pregnancy prevention: Norethindrone acetate and ethinyl estradiol (FEMLYV) orally disintegrating tablets, the first orally disintegrating tablet to receive FDA approval for pregnancy prevention. The recommended dosage is 1 tablet per day for 28 days, with no doses skipped or taken after 24 hours. However, the efficacy of this regimen has not been evaluated in women with a body mass index over 35 kg/m². (Approved 7/22/24, Millicent Puerto Rico LLC)

For full prescribing information, please click here.

Opioid overdose: Nalmefene injection (Zurnai), 1.5 mg, is an opioid antagonist autoinjector indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and children aged 12 years and older, as manifested by respiratory and/or central nervous system depression. It is for intramuscular and subcutaneous use only and is not a substitute for emergency medical care. It is contraindicated in individuals known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product. If the patient does not respond or responds and then relapses into respiratory depression, additional doses may be administered using a new prefilled autoinjector every 2 to 5 minutes until emergency medical assistance arrives. (Approved 8/7/24, Purdue Pharma LP)

For full prescribing information, please click here.

Atopic dermatitis: Lebrikizumab-lbkz (Ebglyss) injection, is an interleukin-13 antagonist indicated for the treatment of moderate-to-severe atopic dermatitis in adults and children aged 12 years of age and older who weigh at least 40 kg whose disease is not adequately controlled with topical therapies or when those therapies are not advisable. It can be used with or without topical corticosteroids. Prior to treatment with lebrikizumab, recipients must have completed all age-appropriate vaccinations according to current immunization guidelines. The recommended initial starting dose is 500 mg (two 250 mg injections) at week 0 and 2, followed by 250 mg (1 injection) every 2 weeks until week 16 or later, when adequate clinical response is achieved; after this, maintenance dosing is a single monthly injection (250 mg every 4 weeks). (Approved 9/13/24, Eli Lilly and Company)

For full prescribing information, please click here.

Alzheimer disease: Donanemab (Kisunla) once-monthly injection, is an amyloid beta-directed antibody indicated for the treatment of adults with early symptomatic Alzheimer disease, including those with mild cognitive impairment and those with the mild dementia stage of AD, with confirmed amyloid pathology. It is the third antiamyloid therapy to be approved by the FDA, but it is the first with evidence to support limited-duration treatment based on amyloid plaque removal. (Approved 7/2/24, Eli Lilly and Company)

For full prescribing information, please click here.