The FDA has approved Entadfi (Veru), a fixed-dose combination of the 5α-reductase inhibitor finasteride and the phosphodiesterase type 5 (PDE5) inhibitor tadalafil, for initial treatment of benign prostatic hyperplasia (BPH) in men with an enlarged prostate; use of the drug is limited to 26 weeks. Entadfi is the first 5α-reductase inhibitor/PDE5 inhibitor combination to become available in the US. Finasteride (Proscar, and generics) and tadalafil (Cialis, and generics) are also available separately.

The FDA has approved the intravenously administered synthetic vasopressin analog terlipressin (Terlivaz – Mallinckrodt) to improve kidney function in adults with hepatorenal syndrome (HRS) and a rapid decline in kidney function. Terlipressin is the first drug to be approved for this indication in the US; it has been available in Europe and elsewhere for year

Ciprofloxacin, previously available orally (Cipro - Medical Letter, 30:11, 1988) and for ophthalmic use (Ciloxan - Medical Letter, 33:52, May 31, 1991), is now the first fluoroquinolone antibiotic to become available in the USA in an intravenous (IV) formulation. Cipro I.V. (Miles) is being promoted as an alternative to third-generation cephalosporins, aminoglycosides, and other drugs used for treatment of serious infections.

An intranasal spray formulation of the corticosteroid fluticasone propionate (floo tik a sone; Flonase - Allen & Hanburys) has been approved by the US Food and Drug Administration for treatment of seasonal and perennial allergic rhinitis in adults and children more than 12 years old.

Ceftibuten (Cedax - Schering), an oral cephalosporin similar to cefixime (Suprax - Medical Letter, 31:73, 1989), has been approved by the US Food and Drug Administration (FDA) for treatment of acute otitis media, pharyngitis or tonsillitis, and for acute bacterial exacerbations of chronic bronchitis.

Glimepiride (Amaryl - Hoechst Marion Roussel), a new sulfonylurea similar to glyburide and glipizide (Medical Letter, 26:79, 1984), was recently marketed for treatment of patients with non-insulin-dependent diabetes mellitus (NIDDM) not controlled by diet and exercise. The new drug is the first sulfonylurea approved by the US Food and Drug Administration (FDA) for use concurrently with insulin.

Acetaminophen (paracetamol; Tylenol, and others) taken in overdosage can cause severe hepatic injury and death. Acetaminophen poisoning is treated with (N-)acetylcysteine. Available for many years in the US as a solution for inhalation therapy (Mucomyst, and others), it subsequently became available for oral use and was recently marketed in the US for intravenous (IV) use as Acetadote (Cumberland).

Preliminary results from a new study, unpublished but reported in a press release from the National Cancer Institute and widely disseminated in the public press, suggest that raloxifene (Evista) might be a better choice than tamoxifen (Nolvadex, and others) for prevention of breast cancer in high-risk postmenopausal women.

The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (Jevtana – Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel (Taxotere).

The FDA has approved two new oral kinase inhibitors for treatment of unresectable or metastatic melanoma: dabrafenib (Tafinlar – GSK) for melanomas with BRAF V600E mutations and trametinib (Mekinist – GSK) for melanomas with either BRAF V600E or V600K mutations. Dabrafenib is not recommended for patients with wild-type BRAF (BRAF-negative) melanoma, and trametinib is not recommended for patients who have received prior BRAF-inhibitor therapy.