The FDA has licensed the adjuvanted, recombinant varicella zoster virus (VZV) vaccine Shingrix (GSK) for prevention of herpes zoster (shingles) in adults of any age who are or will be at elevated risk because of disease- or therapy-induced immunodeficiency or immunosuppression. Shingrix has been licensed for herpes zoster prevention in adults ≥50 years old since 2017.1 It is the only VZV vaccine currently available in the US; Zostavax, a live-attenuated VZV vaccine, was withdrawn from the market in 2020.

The 0.15% nasal spray formulation of the H₁- antihistamine azelastine hydrochloride (Astepro Allergy; Children's Astepro Allergy – Bayer) is now available over the counter (OTC) for temporary relief of nasal congestion, runny nose, sneezing, and itchy nose due to allergic rhinitis in adults and children ≥6 years old. It is the first intranasal antihistamine to be approved by the FDA for OTC use. Other drugs that are available OTC for treatment of allergic rhinitis symptoms include oral antihistamines, intranasal corticosteroids, and mast cell stabilizers.

Inavolisib (Itovebi – Genentech), an oral kinase inhibitor, has been approved by the FDA for use in combination with palbociclib and fulvestrant for treatment of endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer. This is the first approval for Itovebi; palbociclib and fulvestrant have been available for years for treatment of HR-positive, HER2-negative breast cancer.

Temafloxacin (Omniflox - Abbott) and lomefloxacin (Maxaquin - Searle) are the latest fluoroquinolone antimicrobial agents to be approved by the US Food and Drug Administration (FDA) for oral treatment of various infections. Previously marketed include norfloxacin (Noroxin - Medical Letter, 29:25, 1987), ciprofloxacin (Cipro - Medical Letter, 30:11, 1988), and ofloxacin (Floxin - Medical Letter, 33:71, 1991). Norfloxacin is marketed only for treatment of urinary tract infections, and lomefloxacin only for treatment of urinary tract infections and bronchitis known to be caused by...

Piperacillin/tazobactam (Zosyn - Lederle), an antibiotic combination product, has been approved by the US Food and Drug Administration for intravenous treatment of intra-abdominal, pelvic, skin, and skin-structure infections and for community-acquired pneumonia of moderate severity.

The FDA has approved release of omalizumab (oh mah lye zoo mab; Xolair - Genentech, Novartis), a humanized monoclonal antibody given subcutaneously that binds to immunoglobulin E (IgE). The drug is labeled for patients at least 12 years old with moderate to severe persistent asthma who have shown reactivity to an allergen and whose symptoms are inadequately controlled by an inhaled corticosteroid. The manufacturer claims the drug can help stop allergic reactions before they begin.

Uterine artery embolization (UAE) is an increasingly used alternative to surgery for treatment of uterine fibroids.

The FDA recently approved the monoamine oxidase inhibitor (MAOI) selegiline in a transdermal (patch) formulation (Emsam - Bristol-Myers Squibb/Somerset) for treatment of major depressive disorder. Selegiline is also available in an oral formulation (Eldepryl, and others) for treatment of Parkinson's disease.

Dasatinib (Sprycel - Bristol-Myers Squibb), an inhibitor of multiple tyrosine kinases, has been approved by the FDA for second-line treatment of chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in adults.

The FDA has approved the marketing of a 10% topical gel formulation of the muscarinic receptor antagonist oxybutynin chloride (Gelnique - Watson) for treatment of overactive bladder. Oxybutynin is also available for this indication as oral tablets, an oral syrup and a transdermal patch.