The FDA has approved aclidinium bromide (Tudorza Pressair – Forest), an orally-inhaled long-acting anticholinergic, for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD).

The FDA has approved vedolizumab (Entyvio - Takeda), an intravenous integrin receptor antagonist, for treatment of moderate to severe ulcerative colitis or Crohn's disease in adults who have not responded to, lost response to, or cannot tolerate standard treatment. Natalizumab (Tysabri), another integrin receptor antagonist, has been available for several years for treatment of Crohn's disease and multiple sclerosis.

The FDA has approved reslizumab (Cinqair – Teva), a humanized interleukin-5 (IL-5) antagonist monoclonal antibody, for add-on maintenance treatment of severe asthma in adults who have an eosinophilic phenotype. It is the second IL-5 antagonist to be approved in the US; mepolizumab (Nucala) was approved for the same indication in 2015.

The FDA has approved Kyleena (Bayer), an intrauterine device (IUD) that releases the synthetic progestin levonorgestrel, for prevention of pregnancy. It is the fourth levonorgestrel-releasing IUD to be approved in the US. Like Mirena, which has been available since 2000, Kyleena is approved for up to 5 years of use.

The FDA has approved perfluorohexyloctane ophthalmic solution (Miebo – Bausch+Lomb) for treatment of dry eye disease. Available only by prescription, Miebo is the first ophthalmic product to be approved in the US that specifically targets tear evaporation caused by meibomian gland dysfunction. An ophthalmic solution with a similar name, Meibo Tears (Vista), which contains 0.6% propylene glycol, is available over the counter for dry eye relief.

Two new formulations of existing drugs were recently approved by the FDA for treatment of male androgenetic alopecia. Finasteride, a steroid 5alpha-reductase inhibitor previously marketed in a 5-mg tablet as Proscar for treatment of benign prostatic hyperplasia (Medical Letter, 34:83, 1992), has now been approved in a 1-mg tablet as Propecia (Merck) for oral treatment of men with male pattern hair loss. Minoxidil, a peripheral vasodilator used to treat hypertension, was previously available over the counter in a 2% topical solution (Rogaine, and others) for treatment of androgenetic alopecia...

Tenecteplase, a recombinant variant of human tissue plasminogen activator, is now available for thrombolysis in patients with acute myocardial infarction.

Darbepoetin alfa (Aranesp) has been approved by the FDA for treatment of anemia caused by chronic renal disease and will probably also be approved for use in patients with cancer..

Teriparatide (ter i par' a tide; Forteo - Lilly), a recombinant segment of human parathyroid hormone, has been approved by the FDA for parenteral treatment of osteoporosis in post-menopausal women, and in men with idiopathic or hypogonadal osteoporosis, who are at high risk for fracture. Teriparatide is the first approved treatment for osteoporosis that stimulates bone formation. Other drugs approved for this indication inhibit bone resorption (Treatment Guidelines from the Medical Letter 2002;1:13).

Decitabine (Dacogen - MGI Pharma), a pyrimidine nucleoside analog of cytidine, was approved by the FDA as an orphan drug for treatment of myelodysplastic syndromes (MDS), a heterogeneous group of clonal hemopathies that decrease production of normal blood elements (red cells, white cells and platelets) and are associated with a risk of progression to acute leukemia.