The FDA has approved the over-the-counter (OTC) sale of Nasacort Allergy 24HR (Sanofi), a triamcinolone acetonide nasal spray previously available only by prescription as Nasacort AQ. The OTC product, which is scheduled to be marketed in the spring of 2014, will be the first corticosteroid nasal spray that can be purchased without a prescription in the US. Nasacort Allergy 24HR is approved for use in patients ≥2 years old with nasal allergy symptoms.

Montelukast (Singulair - Merck) is an oral cysteinyl leukotriene D₄ receptor antagonist originally marketed for treatment of asthma. It was approved by the FDA in 2003 for treatment of seasonal allergic rhinitis and recently for use in perennial allergic rhinitis in adults and children ≥ 6 months old. Intranasal corticosteroids have generally been considered the most effective drugs available for prevention and treatment of allergic rhinitis.

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).

Ciclesonide (Omnaris - Sepracor/Nycomed), a once daily corticosteroid nasal spray, is now available for treatment of seasonal allergic rhinitis (SAR) in adults and children ≥6 years old and for perennial allergic rhinitis (PAR) in those ≥12 years old. An orally inhaled formulation of ciclesonide (Alvesco) was recently approved by the FDA for maintenance treatment of asthma, and will be reviewed in a future issue of The Medical Letter

The FDA has approved Ryaltris (Hikma), a fixed-dose combination nasal spray containing the H1-antihistamine olopatadine hydrochloride (Patanase, and generics) and the corticosteroid mometasone furoate (Nasonex 24 HR Allergy, and generics), for treatment of seasonal allergic rhinitis symptoms in persons ≥12 years old. Ryaltris is the second intranasal antihistamine/corticosteroid combination to be approved for this indication; azelastine 0.1%/fluticasone propionate (Dymista, and generics), which is approved for use in persons ≥6 years old, was the first. Both products are available...

The subcutaneously injected interleukin-13 (IL-13) antagonist tralokinumab-ldrm (Adbry – Leo) and the oral Janus kinase (JAK) inhibitors abrocitinib (Cibinqo – Pfizer) and upadacitinib (Rinvoq – Abbvie) have been approved by the FDA for treatment of moderate to severe atopic dermatitis.

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.

Tiotropium bromide inhalation powder (Spiriva HandiHaler - Boehringer Ingelheim), a long-acting anticholinergic agent, has been approved by the FDA for once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Available in Europe since 2002, it is the first long-acting inhaled anticholinergic drug for treatment of COPD. Ipratropium bromide (Atrovent), an anticholinergic used four times daily, has been available in the US for many years.

Some commonly used systemic drugs that may cause pulmonary toxicity are listed in the table below. These adverse effects may sometimes be difficult to distinguish from the underlying disease (JAD Cooper, Jr et al, Am Rev Respir Dis, 133:321, 488, 1986). Pulmonary effects that are part of a generalized reaction or are indirect effects of drugs - on respiratory muscles, for example, or on the immune system - are not included here.

Omlyclo (omalizumab-igec; Celltrion), a biosimilar product interchangeable with the recombinant anti-IgE monoclonal antibody Xolair, has been approved by the FDA for same indications as Xolair (see Table 1). Omlyclo is the first Xolair biosimilar to be approved in the US.