Raloxifene (Evista - Lilly), a benzothiophene that acts on estrogen receptors, has recently been marketed for prevention of postmenopausal osteoporosis. Only estrogen (alone or in combination with a progestin) and the bisphosphonate alendronate (Fosamax) were previously approved by the FDA for this indication.

Extracts made from leaves of the ginkgo tree (Ginkgo biloba) are available in the uSA as deitary supplements, in France and Germany as licensed drugs and worldwide as herbal remedies for treatment of dementia and many other indications.

Sucralose (Splenda - McNeil Specialty) has been approved by the FDA for use as a nonnutritive sweetener in beverages, baked goods and other foods, and as a tabletop sugar substitute (Fed Reg, 63:16417, April 3, 1998). Other non-caloric sweeteners available in the USA include saccharin (Sweet'n Low, and others), aspartame (NutraSweet, Equal) and acesulfame potassium (Sunette - Medical Letter, 30:116, 1988).

The FDA has approved the use of ulipristal acetate (ella – Watson) as an emergency contraceptive that can be taken up to 5 days after unprotected intercourse. It is available only by prescription.

The FDA has approved tesamorelin (Egrifta – EMD Serono), an injectable synthetic analog of growth-hormone- releasing factor (GRF), for reduction of excess abdominal fat in patients with lipodystrophy associated with HIV infection. Growth hormone (somatropin – Serostim; EMD Serono) has been available for years for treatment of HIV wasting.

Renal sympathetic denervation is under investigation as a therapeutic option for hypertension that has not responded to ≥3 antihypertensive drugs (resistant hypertension).

The FDA has approved idarucizumab (Praxbind – Boehringer Ingelheim) for urgent reversal of the anticoagulant effect of the direct thrombin inhibitor dabigatran etexilate (Pradaxa). Idarucizumab is the first specific reversal agent to become available for one of the new oral anticoagulants.

The FDA has approved the oral poly (ADP-ribose) polymerase (PARP) inhibitor olaparib (Lynparza – Astra-Zeneca) as monotherapy for treatment of women with advanced ovarian cancer who have BRCA1/2 germline mutations and have received at least 3 prior lines of chemotherapy. Olaparib is the first PARP inhibitor to be approved in the US. It is approved outside the US for maintenance treatment of relapsed BRCA-mutated ovarian cancer.

The FDA has approved asfotase alfa (Strensiq – Alexion), a recombinant form of tissue-nonspecific alkaline phosphatase, for subcutaneous treatment of perinatal-, infantile-, and juvenile-onset hypophosphatasia. Asfotase alfa is the first treatment to be approved in the US for this rare genetic metabolic disorder.

Apalutamide (Erleada – Janssen) has received accelerated approval from the FDA for treatment of nonmetastatic castration-resistant prostate cancer. It is the first drug to be approved in the US for this indication. Apalutamide is an oral antiandrogen that binds to the ligand-binding domain of the androgen receptor.