The FDA has approved use of gamma hydroxybutyrate (sodium oxybate is the official generic name; Xyrem - Orphan Medical) for oral treatment of cataplexy in patients with narcolepsy. Gamma hydroxybutyrate (GHB), a metabolite of gamma-aminobutyric acid (GABA), is a central-nervous-system depressant marketed in Europe for use in general anesthesia. In recent years it has been notorious for its use in "date-rape" (Medical Letter 2002; 44:21). Xyrem is a Schedule III controlled substance.

The nonsteroidal anti-inflammatory drug (NSAID) diclofenac, has been approved by the FDA in a 1% topical gel formulation (Voltaren Gel - Endo) for treatment of osteoarthritis (OA). A 3% topical diclofenac gel (Solaraze) is currently approved for treatment of actinic keratoses, but not for topical use on joints. No other topical NSAIDs are approved by the FDA for OA. A diclofenac patch (Flector) was recently approved by the FDA for treatment of pain due to minor strains, sprains and contusions.

Fluvoxamine maleate, a selective serotonin reuptake inhibitor (SSRI) that has been available for many years in an immediate-release formulation (Luvox, and others) for treatment of obsessive-compulsive disorder (OCD) in children and adults, has now been approved by the FDA in an extended-release formulation (Luvox CR - Jazz Pharmaceuticals) for treatment of OCD and social anxiety disorder (SAD) in adults.

Bendamustine HCl (Treanda - Cephalon), an unusual DNA-alkylating agent that has been used in Europe for many years to treat lymphoma, has now been approved by the FDA for treatment of chronic lymphocytic leukemia (CLL) and non-Hodgkin's lymphoma (NHL).

Infertility occurs in about 15% of couples. About one-third of cases are due to problems with ovulation or other female factors, another third are due to a male infertility factor, and the remaining third are unexplained. In older women, unexplained infertility is probably caused by diminished quality and quantity of oocytes. The first approach to treatment of female-factor infertility generally is the use of drugs that stimulate oocyte production.

The FDA has approved extended-release (ER) calcifediol (25-hydroxyvitamin D3; Rayaldee – Opko), a prohormone of calcitriol, the active form of vitamin D3. It is indicated for treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) who have serum total 25-hydroxyvitamin D levels <30 ng/mL.

The FDA has approved two new drugs for sickle cell disease: crizanlizumab-tmca (Adakveo – Novartis), an IV P-selectin blocker, and voxelotor (Oxbryta – GBT), an oral hemoglobin S (HbS) polymerization inhibitor.

The FDA has approved a sublingual fi lm formulation of the nonergot dopamine agonist apomorphine (Kynmobi – Sunovion) for acute, intermittent treatment of "off" episodes in patients with Parkinson's disease (PD). A subcutaneous formulation of apomorphine (Apokyn) has been available for years for the same indication in patients with advanced PD.

Myfembree (Myovant/Pfizer), an oral fixed-dose combination of the gonadotropin-releasing hormone (GnRH) receptor antagonist relugolix, the estrogen estradiol, and the progestin norethindrone acetate, has been approved by the FDA for management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. It is the second product to be approved in the US for this indication; Oriahnn, which contains the GnRH receptor antagonist elagolix in combination with estradiol and norethindrone acetate, was approved earlier. Relugolix was approved for...

Several currently available antiemetic drugs can prevent vomiting caused by cancer chemotherapy. Anticancer drugs that cause vomiting are listed in the table below.