The FDA has approved nivolumab (Opdivo – BMS), an IV programmed death receptor-1 (PD-1) blocking antibody, for treatment of unresectable or metastatic melanoma that has progressed following treatment with ipilimumab (and a BRAF inhibitor in patients who are BRAF V600 mutation positive) and for treatment of metastatic squamous non-small cell lung cancer (NSCLC) that has progressed on or after platinum-based chemotherapy. It is the second PD-1 inhibitor to be marketed in the US after pembrolizumab (Keytruda), and the first to be approved for treatment of NSCLC.

The FDA has approved two new drugs for treatment of adults with acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria. Dalbavancin (Dalvance – Durata) is a long-acting intravenous (IV) lipoglycopeptide antibiotic similar to telavancin (Vibativ). Tedizolid phosphate (Sivextro – Cubist) is an IV and oral oxazolidinone antibacterial drug similar to linezolid (Zyvox). A third IV antibiotic, oritavancin (Orbactiv), recently approved by the FDA for the same indication, will be reviewed in a future...

The FDA has approved IV amisulpride (Barhemsys – Acacia), a selective dopamine-2 and -3 (D₂/D₃) receptor antagonist, for prevention and treatment of postoperative nausea and vomiting (PONV) in adults. It is the first antiemetic to be approved for rescue treatment of PONV in patients who have symptoms despite receiving antiemetic prophylaxis. Oral formulations of amisulpride are available in Europe for treatment of schizophrenia and acute psychotic episodes.

The FDA has licensed two new pneumococcal conjugate vaccines (PCVs) for prevention of invasive pneumococcal disease in adults: Prevnar 20 (PCV20; Pfizer), which contains antigens from 20 serotypes of pneumococcus, and Vaxneuvance (PCV15; Merck), which contains antigens from 15 serotypes. Two other pneumococcal vaccines are available in the US: Prevnar 13 (PCV13; Pfizer), a 13-valent conjugate vaccine licensed for use in persons ≥6 weeks old, and Pneumovax 23 (PPSV23; Merck), a 23-valent pneumococcal polysaccharide vaccine licensed for use in persons ≥2 years...

The drugs of choice for treatment of viral infections (other than HIV) and their dosages are listed in Tables 1-6 on the pages that follow. Some of the indications and dosages recommended here have not been approved by the FDA. Vaccines used for the prevention of viral infections are discussed elsewhere.

The CDC Advisory Committee on Immunization Practices (ACIP) recommends certain vaccines for adults residing in the US. The American Academy of Family Physicians has also recently published an adult immunization schedule. Recommendations for vaccination against COVID-19 and seasonal influenza will be reviewed separately.

Becaplermin (be kap' ler min; Regranex - Ortho-McNeil), a 0.01% topical gel formulation of recombinant human platelet-derived growth factor (rhPDGF), was recently approved by the FDA for adjunctive treatment of diabetic ulcers of the lower extremities that extend subcutaneously or beyond and have an adequate blood supply. Endogenous platelet-derived growth factor increases proliferation of cells that repair wounds and form granulation tissue.

Pioglitazone is the third thiazolidinedione ("glitazone") to be marketed in the USA for treatment of type 2 diabetes. Thiazolidinediones decrease resistance to insulin.

The FDA now requires boxed warnings in the package inserts of benzodiazepines describing the potential for these drugs to be abused and misused and to cause addiction and physical dependence. Benzodiazepine labels have contained a boxed warning about a risk of serious drug interactions with opioids since 2016.

The direct oral anticoagulants (DOACs) apixaban (Eliquis) and rivaroxaban (Xarelto, and generics) are frequently used for treatment of acute venous thromboembolism (VTE) and are usually continued for at least 3 months. The other DOACs (edoxaban [Savaysa] and dabigatran [Pradaxa, and generics]) are alternatives for long-term treatment, but they require prior treatment with low-molecular-weight heparin for ≥5 days. Until recently, no large randomized trial directly comparing the safety of apixaban and rivaroxaban for treatment of VTE was available.