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.

The oral sphingosine 1-phosphate (S1P) receptor modulator etrasimod (Velsipity – Pfizer) has been approved by the FDA for treatment of moderately to severely active ulcerative colitis in adults. It is the second oral S1P receptor modulator to be approved in the US for this indication; ozanimod (Zeposia) was the first.

The FDA has approved the sodium/hydrogen exchanger 3 (NHE3) inhibitor tenapanor (Xphozah – Ardelyx) to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy when phosphate binders are ineffective or as monotherapy when phosphate binders cannot be tolerated. Tenapanor is the first NHE3 inhibitor to be approved in the US for hyperphosphatemia. It was previously approved as Ibsrela to treat irritable bowel syndrome with constipation (IBS-C).

The FDA has approved ensifentrine (Ohtuvayre – Verona), an inhaled phosphodiesterase (PDE) 3 and 4 inhibitor, for maintenance treatment of chronic obstructive pulmonary disease (COPD) in adults. It is the first dual inhibitor of PDE3 and PDE4 to be approved by the FDA, and the first inhaled drug with a new mechanism of action to be approved for treatment of COPD in more than 20 years.

The FDA has licensed Capvaxive (PCV21; Merck), a 21-valent pneumococcal conjugate vaccine, for prevention of invasive pneumococcal disease (IPD) and pneumococcal pneumonia in adults. Four other pneumococcal vaccines are currently available in the US: Prevnar 20 (PCV20), Vaxneuvance (PCV15), and Prevnar 13 (PCV13) are conjugate vaccines licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23) is a pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years old (see Table 1).

The 1990 labeling for Norpramin, the Merrell Dow brand of the tricyclic antidepressant desipramine, reports the occurrence of sudden death in an eight-year-old child treated with the drug. Desipramine is also available as Pertofrane (Rorer) and generically.

The FDA has approved the marketing of RotaShield, a live oral vaccine for prevention of infantile rotavirus infection. Rotaviruses are segmented double-stranded RNA viruses that are the most common cause of severe diarrhea and dehydration in infants and young children.

The FDA has approved Juvisync (Merck), a fixed-dose combination of the antihyperglycemic DPP-4 inhibitor sitagliptin (Januvia) and the HMG-CoA reductase inhibitor simvastatin (Zocor, and others).

Recent reports indicate that intramuscular (IM) injection of the nonsteroidal anti-inflammatory drug (NSAID) ketorolac (Toradol, and others), sometimes directly into injured muscles, has become a common practice in US locker rooms.

Truvada (Gilead), an oral fixed-dose combination of the antiretrovirals emtricitabine and tenofovir disoproxil fumarate frequently used for treatment of HIV infection,1 has now also been approved by the FDA for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 in adults at high risk. It is the first drug to be approved for this indication. The CDC has been recommending Truvada off-label for pre-exposure prophylaxis in men who have sex with men since 2011.2 A 30-day supply of Truvada costs about $1160.3CLINICAL STUDIES — Approval for the new indication was based on 2...