The FDA has approved Duexis (Horizon), a fixed-dose combination of the nonsteroidal anti-inflammatory drug (NSAID) ibuprofen and the H2-receptor antagonist (H2RA) famotidine, for symptomatic relief of osteoarthritis and rheumatoid arthritis and to decrease the risk of developing gastric and duodenal ulcers in patients at risk for NSAID-associated ulcers. Vimovo, a combination of the NSAID naproxen and the proton pump inhibitor (PPI) esomeprazole, is also approved by the FDA for prevention of NSAID-associated gastric ulcers.

Tyrvaya (Oyster Point), a nasal spray formulation of the cholinergic agonist varenicline, has been approved by the FDA for treatment of dry eye disease. It is the first nasal spray to be approved in the US for this indication. An oral formulation of varenicline (Chantix, and generics) has been available for years for smoking cessation.

Olodaterol (Striverdi Respimat – Boehringer Ingelheim), a new inhaled long-acting beta2-agonist, has been approved by the FDA for once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD). It is not approved for treatment of acute exacerbations of COPD or for treatment of asthma. Olodaterol is the third long-acting beta2-agonist to be approved by the FDA for once-daily use; indacaterol (Arcapta Neohaler), which is available as a single agent, and vilanterol, which is available only in fixed-dose combinations with the...

Tildrakizumab-asmn (Ilumya – Sun), an interleukin (IL)-23 antagonist, has been approved by the FDA for treatment of adults with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab is the second selective IL-23 antagonist to be approved for this indication; guselkumab (Tremfya) was the first.

The interleukin (IL)-23 antagonist guselkumab (Tremfya – Janssen Biotech) has now been approved by the FDA for treatment of moderately to severely active ulcerative colitis (UC) in adults; it was approved earlier for treatment of plaque psoriasis and psoriatic arthritis. Guselkumab is the third IL-23 antagonist to be approved in the US for treatment of UC; risankizumab (Skyrizi) and mirikizumab (Omvoh) were approved earlier.

Pegloticase (Krystexxa – Savient), a PEGylated urate oxidase enzyme, has been approved by the FDA for intravenous (IV) treatment of chronic symptomatic gout in adults who have not responded to maximum doses of a xanthine oxidase inhibitor, such as allopurinol (Zyloprim, and others). Pegloticase is the second new drug approved for gout in more than 40 years; a new xanthine oxidase inhibitor, febuxostat (Uloric), was approved in 2009.

The FDA has approved an inhaled fixed-dose combination of the long-acting anticholinergic umeclidinium (ue mek" li din' ee um) and the long-acting beta₂-adrenergic agonist (LABA) vilanterol (Anoro Ellipta – GSK/Theravance) for once-daily maintenance treatment of chronic obstructive pulmonary disease (COPD). Anoro Ellipta is the first product available in the US that combines two long-acting bronchodilators in a single delivery device.

The FDA has approved 3 allergen extracts for sublingual administration as immunotherapy for allergic rhinitis confirmed by a positive skin test or in vitro testing for pollen-specific IgE antibodies: Oralair (Stallergenes S.A./Greer) and Grastek (Merck) for grass pollen-induced allergic rhinitis and Ragwitek (Merck) for short ragweed pollen-induced allergic rhinitis.

The FDA has approved Vivlodex (Iroko), a low-dose formulation of the nonsteroidal anti-inflammatory drug meloxicam (Mobic, and generics), for management of osteoarthritis pain. According to the manufacturer, the new formulation aligns with stronger FDA warnings about the cardiovascular risks of NSAIDs and the recommendation to use the lowest possible doses of these drugs.

The FDA has approved Verkazia (Santen), a 0.1% ophthalmic emulsion formulation of the calcineurin inhibitor cyclosporine, for treatment of vernal keratoconjunctivitis (VKC). Verkazia is the first product to be approved in the US for this indication.