The FDA has approved oral and injectable formulations of the HIV-1 capsid inhibitor lenacapavir (Yeztugo – Gilead) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in at-risk adolescents and adults. Lenacapavir is the first drug to be approved for this indication that is given twice-yearly; other drugs approved for this indication are given once daily or once every 2 months. Lenacapavir was approved in 2022 as Sunlenca for use with other antiretroviral drugs to treat multidrug-resistant HIV-1 infection (MDR-HIV) in heavily treatment-experienced...

The FDA has approved two new ophthalmic drugs for reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension: latanoprostene bunod (Vyzulta – Bausch and Lomb), a modified prostaglandin analog, and netarsudil (VRhopressa – Aerie), the first Rho kinase inhibitor to be approved in the US.

The FDA has approved a new low-dose sublingual tablet formulation of the benzodiazepine receptor agonist zolpidem tartrate (Intermezzo – Transcept/Purdue) for treatment of insomnia due to middle-of-the-night awakening. Ambien and other zolpidem formulations available in the US are labeled for use only at bedtime.

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

The FDA has approved a 1% cream formulation of the antiparasitic drug ivermectin (Soolantra – Galderma) for topical treatment of inflammatory lesions of rosacea. Ivermectin is available in the US in tablets (Stromectol, and generics) for treatment of onchocerciasis and other worm infestations and as a 0.5% lotion (Sklice) for treatment of head lice.

The FDA has approved cariprazine (Vraylar – Actavis), an oral, once-daily, second-generation antipsychotic, for treatment of schizophrenia and for acute treatment of manic or mixed episodes associated with bipolar I disorder.

Levalbuterol, the R-isomer of racemic albuterol, has been approved by the FDA for prevention and treatment of bronchospasm in patients at least 12 years old.

Alcaftadine (Lastacaft – Allergan), an ophthalmic H₁-antihistamine, has been approved by the FDA for prevention of itching associated with allergic conjunctivitis in patients > 2 years old.

The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for treatment of type 2 diabetes.

The FDA has approved rolapitant (Varubi – Tesaro), an oral substance P/neurokinin 1 (NK₁) receptor antagonist, for use with other antiemetics to prevent delayed nausea and vomiting associated with cancer chemotherapy in adults. It is the third substance P/NK₁ receptor antagonist to be approved in the US; aprepitant (Emend) and netupitant (only available in combination with the 5-HT₃ receptor antagonist palonosetron as Akynzeo) were approved earlier for prevention of both acute and delayed chemotherapy-induced nausea and vomiting.