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The FDA has approved fenfluramine oral solution (Fintepla – Zogenix) for treatment of seizures in patients ≥2 years old with Dravet syndrome. It is the third drug to be approved for this indication. Stiripentol (Diacomit) and cannabidiol (Epidiolex), a purified product derived from marijuana, were approved earlier.

The FDA has required the manufacturers of the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna) to revise their labels to include updated information about the risks of myocarditis/pericarditis. The FDA requested that the manufacturers submit the proposed labeling changes or contest the agency's requirement for the safety update by May 17, 2025. As of June 4th, to our knowledge, the labels of Comirnaty and Spikevax have not been updated and neither manufacturer has submitted a rebuttal.

The FDA has approved a 4% aerosol foam formulation of minocycline (Amzeeq – Foamix) for topical treatment of inflammatory lesions of non-nodular moderate to severe acne in patients ≥9 years old. It is the first topical tetracycline formulation to be approved for use in patients with acne. Oral minocycline (Minocin, Solodyn, and generics) is

Penciclovir 1% cream (Denavir - SmithKline Beecham) has been approved by the US Food and Drug Administration (FDA) for treatment of recurrent orolabial herpes simplex virus (HSV) infections in adults. Acyclovir (Zovirax) is also available in a topical formulation for treatment of herpes simplex infections, but is approved by the FDA only for use in immunocompromised patients. Oral drugs approved for treatment of some herpes simplex infections, but not recurrent orolabial infections, include acyclovir, valacyclovir (Valtrex) and famciclovir (Famvir), which is rapidly hydrolyzed to...

A new synthetic conjugated estrogen product (Cenestin - Duramed) was recently approved by the US Food and Drug Administration for treatment of vasomotor symptoms due to estrogen deficiency.

The FDA has approved the selective alpha₂-adrenergic receptor agonist brimonidine as a 0.33% gel (Mirvaso – Galderma) for topical treatment of adults with persistent facial erythema of rosacea. Brimonidine is also available in ophthalmic formulations for treatment of glaucoma.

Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...

Since our initial review of the oral lipid-lowering adenosine triphosphate-citrate lyase (ACL) inhibitor bempedoic acid (Nexletol – Esperion) in 2020, cardiovascular outcomes data in statin-intolerant patients have become available.

The oral kinase inhibitors dabrafenib (Tafinlar – GSK) and trametinib (Mekinist – Novartis) have been approved by the FDA for use together for a sixth indication: treatment of low-grade glioma (LGG) with a BRAF V600E mutation in patients ≥1 years old who require systemic therapy. This combination is the first systemic therapy to be approved in the US for first-line treatment of LGG with a BRAF V600E mutation in pediatric patients. The FDA also approved new oral formulations of both drugs for patients who are unable to swallow dabrafenib capsules or trametinib...