Roflumilast (Daliresp – Forest), an oral phosphodiesterase 4 (PDE4) inhibitor, was approved by the FDA to reduce the risk of exacerbations in adult patients with severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis and a history of exacerbations.

The FDA has approved ruxolitinib (Jakafi – Incyte), a janus-associated kinase (JAK) inhibitor, for treatment of myelofibrosis. Jakafi is the first JAK inhibitor to be approved for any indication and the only drug approved for treatment of myelofibrosis.

Metreleptin (Myalept – Amylin), a recombinant leptin analog produced in E. coli, has been approved by the FDA to treat the complications of leptin deficiency in patients with congenital or acquired generalized lipodystrophy. It has not been approved to date for the treatment of partial lipodystrophies, including those associated with the use of protease inhibitors in patients with HIV. Metreleptin is approved in Japan for the treatment of any lipodystrophy disorder.

Rheumatoid arthritis (RA) is prevalent in 0.5% of adults in the US; it is about 2.5 times more common in women than in men. Guidelines for treatment of RA from the American College of Rheumatology were recently updated. The goal of treatment is to minimize disease activity and prevent irreversible joint damage.

Infertility occurs in about 15% of couples. About one third of infertility is due to problems with ovulation or an anatomic abnormality of the fallopian tube or peritoneum, such as scarring, adhesions or endometriosis. Another third is due to a male infertility factor, most commonly insufficient sperm production or abnormal motility or morphology. The remaining third is unexplained. In older women unexplained infertility is probably caused by diminished quality and quantity of oocytes, decreased implantation and spontaneous pregnancy wastage.

Cetirizine (Zyrtec - Pfizer), a histamine H 1 -receptor antagonist, has been approved by the US Food and Drug Administration for treatment of seasonal allergic rhinitis, perennial allergic rhinitis and chronic idiopathic urticaria in adults and children more than 12 years old.

Terbinafine (Lamisil - Sandoz), an allylamine synthetic antifungal, previously available in the USA in a topical formulation (Medical Letter, 35:76, 1993) has now been marketed for oral use in the treatment of fungal nail infections caused by dermatophytes. Oral terbinafine has been available in Europe since 1992.

Imatinib mesylate (STI-571; Gleevec - Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of all phases of chronic myeloid leukemia (CML) after interferon has failed.

Metformin (Glucophage, and others) is generally preferred as the first-line agent for treatment of type 2 diabetes, but most patients subsequently require treatment with more than one drug. Many combination products have been marketed; the latest of these combines saxagliptin with extended-release (ER) metformin as Kombiglyze XR.

The FDA has approved the Janus kinase (JAK) inhibitor baricitinib (Olumiant – Lilly) for oral treatment of adults with moderately to severely active rheumatoid arthritis (RA) that has not responded adequately to one or more tumor necrosis factor (TNF) inhibitors. Baricitinib is the second JAK inhibitor to be approved for treatment of RA; tofacitinib (Xeljanz, Xeljanz XR) was the first.