The FDA has approved a 1.5% topical foam formulation of minocycline (Zilxi – Foamix) for treatment of inflammatory lesions of rosacea in adults. It is the only topical minocycline product approved for this indication. The same manufacturer markets minocycline foam 4% (Amzeeq) for treatment of acne in patients ≥9 years old.

In recently published clinical trials, once-weekly subcutaneous injection of the glucagon-like peptide 1 (GLP-1) receptor agonist semaglutide (Ozempic – Novo Nordisk), which is FDA-approved for treatment of type 2 diabetes and to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease, has reduced body weight significantly in patients with and without type 2 diabetes when given in addition to lifestyle intervention. Liraglutide (Saxenda), another GLP-1 receptor agonist, has been FDA-approved for chronic weight...

The FDA has approved dasiglucagon (Zegalogue – Zealand) for subcutaneous (SC) treatment of severe hypoglycemia in patients ≥6 years old with diabetes. Dasiglucagon is the third glucagon product to be marketed in the US that does not require reconstitution before administration; Gvoke, a SC formulation approved for use in patients ≥2 years old, and Baqsimi, an intranasal powder approved for use in patients ≥4 years old, have been available since 2019. Injectable glucagon emergency kits (GlucaGen HypoKit, and generics) have been available for years, but they require...

Rosacea is a common, chronic inflammatory facial eruption of unknown cause. It is more prevalent in women than in men, and disease onset typically occurs after age 30. Rosacea is characterized by erythema, telangiectasia, and flushing, and sometimes by recurrent, progressive crops of acneiform papules and pustules, usually on the central part of the face. Some patients develop granulomas and tissue hypertrophy, which may lead to rhinophyma (a bulbous nose), particularly in men. Blepharitis and conjunctivitis are common. Keratitis and corneal scarring occur rarely.

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.

FluMist (MedImmune), the first live-attenuated and first intranasally administered influenza vaccine, has been approved by the FDA to prevent influenza in healthy people 5-49 years old. Given as a nasal spray, it stimulates immunity by viral replication in the upper respiratory tract. This vaccine apparently will be advertised directly to the public as a "needle-free" alternative to intramuscular influenza vaccine.

The FDA has approved an inhaled fixed-dose combination (Breo Ellipta – GSK/Theravance) of the corticosteroid fluticasone furoate and the long-acting beta₂-adrenergic agonist (LABA) vilanterol trifenatate for once-daily treatment of chronic obstructive pulmonary disease (COPD).

The FDA has approved peramivir (Rapivab – BioCryst), an IV neuraminidase inhibitor administered as a single dose, for treatment of acute uncomplicated influenza in patients ≥18 years old who have had symptoms for no more than 2 days. Peramivir was available temporarily in the US during the 2009-2010 influenza season under an emergency use authorization for treatment of hospitalized patients. It has been available in some Asian countries since 2010. Peramivir is the third neuraminidase inhibitor to be approved in the US. Oseltamivir (Tamiflu), which is taken orally, and zanamivir...

The FDA has approved a sublingual fi lm formulation of the nonergot dopamine agonist apomorphine (Kynmobi – Sunovion) for acute, intermittent treatment of "off" episodes in patients with Parkinson's disease (PD). A subcutaneous formulation of apomorphine (Apokyn) has been available for years for the same indication in patients with advanced PD.

Oriahnn (Abbvie), a fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist elagolix, the estrogen estradiol, and the progestin norethindrone acetate copackaged with elagolix alone, has been approved by the FDA for oral treatment of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the first product to be approved in the US for this indication. Elagolix (Orilissa) has been available since 2018 for treatment of moderate to severe pain associated with endometriosis. The GnRH receptor antagonist...