The FDA has approved a two-dose hepatitis B virus (HBV) vaccine (Heplisav-B – Dynavax) for use in adults ≥18 years old. The three other HBV vaccines marketed in the US are usually administered in 3 doses. Engerix-B and Recombivax HB are licensed for use in persons of all ages. A combination hepatitis A/B vaccine (Twinrix) contains the same hepatitis B component as Engerix-B and is licensed for use only in adults.

The FDA has approved a combination oral contraceptive containing the estrogen estetrol and the progestin drospirenone (Nextstellis – Mithra/Mayne). Estetrol is the first new estrogen to become available in the US in 50 years. Drospirenone is available alone (Slynd) and in combinations with the estrogen ethinyl estradiol for prevention of pregnancy.

View the Comparison Table: Some FDA-Approved Drugs for Weight Management

Idarubicin hydrochloride (Idamycin - Adria), an anthracycline structurally related to daunorubicin (Cerubidine, and others) and doxorubicin (Adriamycin, and others), was recently approved in the USA for treatment of acute myelogenous leukemia (AML) in adults.

An advertisement in a recent issue of Ophthalmology introduces PreserVision Eye Vitamin AREDS 2 Formula from Bausch & Lomb. No specific indication is mentioned, but the ad states that “…[the new product] builds on the original PreserVision Eye Vitamin AREDS Formula, the only formula proven to slow the progression of moderate-to-advanced AMD.”

Long-term use of bisphosphonates for prevention and treatment of osteoporosis has been associated with osteonecrosis of the jaw, atypical fractures of the femur, and possibly esophageal cancer. So for how long should patients take them?

Excessive exposure to ultraviolet (UV) radiation is associated with sunburn, photoaging, and skin cancer. Sunscreens are widely used to reduce these risks, but questions remain about their effectiveness and safety. The FDA has issued a proposed rule that would require manufacturers to perform additional safety studies for some sunscreen active ingredients and would mandate better UVA protection in sunscreen products. Some sunscreen products containing FDA-approved active ingredients are listed in Table 2.

Photopheresis is a new technique recently approved by the US Food and Drug Administration for treatment of cutaneous T-cell lymphoma. It combines oral administration of a photoactivatable cytotoxic drug with leukapheresis and extracorporeal exposure of leukocytes to long-wave ultraviolet light (UVA). This procedure requires use of a 'UVAR Instrument' manufactured by Therakos, a subdivision of Johnson and Johnson.

To avoid the morbidity and occasional mortality of transurethral resection or open prostatectomy, some urologists are now using balloon dilatation of the prostatic urethra to treat benign prostatic hypertrophy.

Gonadorelin (goe nad oh rell'; in) acetate (Lutrepulse - Ortho), a synthetic decapeptide identical in amino acid sequence to human gonadotropin-releasing hormone (GnRH), was recently approved by the US Food and Drug Administration for treatment of primary hypothalamic amenorrhea. Gonadorelin hydrochloride (Factrel) was previously available for diagnostic use (Medical Letter, 25:106, 1983). Analogs of GnRH have been used to treat endometriosis and advanced cancer of the prostate (Medical Letter, 27:71, 1985).