The FDA has approved Trelegy Ellipta (GSK), a fixed-dose combination of the inhaled corticosteroid (ICS) fluticasone furoate, the long-acting antimuscarinic agent (LAMA) umeclidinium, and the long-acting beta₂-agonist (LABA) vilanterol. It is available as a dry powder inhaler for once-daily maintenance treatment of COPD and to reduce COPD exacerbations in patients with a history of exacerbations. Trelegy Ellipta is the first three-drug inhaler for treatment of COPD to become available in the US.

An oral formulation of mesalamine (5-aminosalicylic acid, 5-ASA, Asacol - Proctor & Gamble), was recently approved by the US Food and Drug Administration (FDA) for treatment of mildly to moderately active ulcerative colitis; it has not been approved for maintenance of remissions. Olsalazine (Dipentum), a similar drug (Medical Letter, 32:105, 1990), is approved for maintenance of remissions but not for treatment.

An intranasal formulation of the corticosteroid budesonide (Rhinocort Nasal Inhaler - Astra) was recently approved by the US Food and Drug Administration for treatment of seasonal or perennial allergic rhinitis in adults and children and nonallergic perennial rhinitis in adults. Budesonide has been available in Canada and Europe for several years for inhalation treatment of both allergic rhinitis and asthma.

Cevimeline hydrochloride, an acetylcholine derivative, has been approved by the FDA for treatment of dry mouth symptoms caused by Sjogren's syndrome. Presumably it could also be used to treat radiation-induced xerostomia in patients with head and neck cancer. Pilocarpine hydrochloride is FDA-approved for both indications

The FDA has approved crisaborole 2% ointment (Eucrisa – Pfizer) for topical treatment of mild to moderate atopic dermatitis in patients ≥2 years old. It is the first phosphodiesterase type-4 (PDE4) inhibitor to be approved in the US for this indication.

The FDA has approved (Giapreza) (La Jolla), an IV formulation of synthetic angiotensin II, to increase blood pressure in adults with septic or other vasodilatory shock, such as anaphylactic or neurogenic shock. Angiotensin is a naturally occurring peptide hormone in the renin-angiotensin-aldosterone system (RAAS). (Giapreza) is the first synthetic angiotensin II product to become available in the US.

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...

Formoterol fumarate (Perforomist - Dey), a long-acting beta₂-agonist, was recently approved by the FDA as an inhalation solution for nebulization for maintenance treatment of bronchoconstriction associated with chronic obstructive pulmonary disease (COPD). Arformoterol (Brovana), the (R, R)-enantiomer of formoterol, was approved earlier this year for the same indication.

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.

Pneumocystis carinii pneumonia (PCP) occurs in nearly 80% of patients with the acquired immune deficiency syndrome (AIDS) and is a common cause of morbidity and mortality. Oral trimethoprim-sulfamethoxazole (Bactrim; and others), intravenous isethionate (Pentam 300) and other systemic drugs have been used to prevent PCP, but in AIDS patients, all of these agents can occasionally cause severe adverse effects (Medical Letter, 30:94, 1988). Recently, the US Food and Drug Administration approved marketing of aerosolized pentamidine isethionate (NebuPent - LyphoMed) for this indication. Another...