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.

Healthcare providers are often asked if drugs can be used past their expiration date. Because of legal restrictions and liability concerns, manufacturers do not sanction such use and usually do not comment on the safety or effectiveness of their products beyond the date on the label. Since our last article on this subject, more data have become available.

An FDA panel has recommended that stronger warnings about hepatotoxicity be added to the labeling for acetaminophen (www.fda.gov, search "acetaminophen hepatotoxicity").

Ketorolac (kee' toe role ak) tromethamine 0.5%, a nonsteroidal anti-inflammatory drug (NSAID) previously available for parenteral and oral administration (Toradol - Medical Letter, 32:79, 1990), has now been approved for ophthalmic use (Acular - Allergan, Fisons) to relieve itching in seasonal allergic conjunctivitis. NSAIDs decrease prostaglandin concentrations in the eye, which theoretically might contribute to a decrease in itching. Several other NSAIDs are available for ophthalmic use in the USA, but none is marketed for this indication. Flurbiprofen (Ocufen) and suprofen (Profenal) ...

Radicava ORS, an oral suspension formulation of the free radical scavenger edaravone (Mitsubishi Tanabe Pharma), has been approved by the FDA for treatment of amyotrophic lateral sclerosis (ALS). An IV formulation of edaravone (Radicava) has been available since 2017.

The FDA has approved a nasal spray fixed-dose combination (Dymista – Meda) of the H₁-antihistamine azelastine (Astelin, Astepro, and generics) and the corticosteroid fluticasone propionate (Flonase, and generics) for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old who need both medications for symptomatic relief. It is the first nasal spray to be approved in the US that contains both an H₁-antihistamine and a corticosteroid.

Quzyttir (TerSera), an IV formulation of the second-generation H1-antihistamine cetirizine, has been approved by the FDA for treatment of acute urticaria in patients ≥6 months old. Oral formulations of cetirizine (Zyrtec, and others) have been for sale over the counter for years. Quzyttir is the first parenteral formulation of a second-generation H1-antihistamine to become available in the US; parenteral formulations of two first-generation H1-antihistamines, diphenhydramine (Benadryl, and others) and hydroxyzine (Vistaril, and others), have been available for many...

Breathe Right, an adhesive bandage device that pulls open the nostrils, has been approved by the US Food and Drug Administration and is being heavily promoted to the general public as a treatment for snoring and night-time nasal congestion. The manufacturer's suggested retail price is $4.99 for a box of 10 strips.

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.

A new formulation of the H1-antihistamine azelastine hydrochloride 0.1% nasal spray (Astepro - Meda) has been approved by the FDA for treatment of seasonal allergic rhinitis (SAR) in patients ≥12 years old and is being heavily advertised to the public on radio, television and the Internet. All azelastine products require a prescription.