The FDA has approved Bijuva (TherapeuticsMD), a fixed-dose combination of estradiol and progesterone, for oral treatment of moderate to severe vasomotor symptoms (hot flashes) due to menopause in women with an intact uterus. The manufacturer is marketing Bijuva as "the first and only FDA-approved combination of bio-identical estradiol and bio-identical progesterone in a single daily oral capsule".

The FDA has approved the use of nitroglycerin ointment 0.4% (Rectiv – ProStrakan/Aptalis) for treatment of moderate to severe pain associated with chronic anal fissure; the same drug is marketed as Rectogesic in Europe. Nitroglycerin ointment 2% (Nitro-Bid) is available in the US for prevention of angina.

Nitazoxanide (Alinia - Romark Labs), a new antiparasitic drug, has been approved by the FDA in a liquid formulation for treatment of diarrhea caused by Cryptosporidium parvum and Giardia lamblia in children 1 to 11 years old. It is the first drug approved for treatment of cryptosporidiosis and the first to become available as a liquid for treatment of giardiasis. The FDA is reviewing a tablet formulation of nitazoxanide for use in adults.

Phytoestrogens, plant compounds that are converted to estrogens in the gut, are widely promoted as "natural"substitutes for estrogen in hormone replacement therapy.

Recombinant interferon alfa-2b conjugated to polyethylene glycol (PEG-Intron), the first "pegylated"alpha interferon, has been approved by the FDA for once-a-week monotherapy of chronic hepatitis C virus (HCV) infection in patients not previously treated with alpha interferon.

Omeprazole (Losec - Merck), a new drug that suppresses gastric acid secretion, has been approved by the US Food and Drug Administration for short-term (four to eight weeks) treatment of severe or refractory gastroesophageal reflux and for long-term treatment of pathological hypersecretory conditions such as Zollinger-Ellison syndrome, multiple endocrine adenomas, and systemic mastocytosis. Although widely used abroad for treatment of peptic ulcers, it has not been approved for that indication in the USA.

The primary symptoms of menopause are genitourinary and vasomotor. The genitourinary syndrome of menopause (GSM) includes symptoms such as burning, irritation, dryness, dyspareunia, dysuria, and recurrent urinary tract infection. Vasomotor symptoms (VMS; hot flashes, night sweats) often disrupt sleep.

Since The Medical Letter last reviewed the choice of benzodiazepines (Volume 23, page 41, 1981), several new drugs have been marketed and some old ones are now available generically. Most of the benzodiazepines available for oral use in the USA are listed in the table on page 28.

Taclonex ointment (Warner Chilcott/LEO Pharma), a combination of the vitamin D3 analog calcipotriene 0.005% (Dovonex) and the high-potency corticosteroid betamethasone dipropionate 0.064%, was recently approved by the FDA for treatment of psoriasis vulgaris in patients ≥ 18 years old.

Celiac disease is a chronic autoimmune disorder caused by a genetic intolerance to gluten that occurs in about 1% of the population. The main form of treatment is a lifelong gluten-free diet.