Two new formulations of existing drugs were recently approved by the FDA for treatment of male androgenetic alopecia. Finasteride, a steroid 5alpha-reductase inhibitor previously marketed in a 5-mg tablet as Proscar for treatment of benign prostatic hyperplasia (Medical Letter, 34:83, 1992), has now been approved in a 1-mg tablet as Propecia (Merck) for oral treatment of men with male pattern hair loss. Minoxidil, a peripheral vasodilator used to treat hypertension, was previously available over the counter in a 2% topical solution (Rogaine, and others) for treatment of androgenetic alopecia...

Rofecoxib, a selective COX-2 inhibitor, has been approved by the FDA for treatment of osteoarthritis, acute pain and menstrual pain.

Perindopril, the tenth angiotensin converting enzyme (ACE) inhibitor to be marketed in the USA, and telmisartan and eprosartan, the fifth and sixth angiotensin receptor blockers, have recently become available for treatment of hypertension.

Nateglinide (Starlix), a new meglitinide oral glucose-lowering agent, has been approved by the FDA.

A vaccine to prevent both Hepatitis A and Hepatitis B (Twinrix), previously licensed in Canada and Europe, is now available in the US for adults.

Olmesartan medoxomil (Benicar - Sankyo), a substituted imidazole, is the seventh oral angiotensin II receptor blocker (ARB) approved by the FDA for treatment of hypertension.

The FDA has approved the marketing of buprenorphine in sublingual tablets (Reckitt Benckiser) both alone (Subutex) and with naloxone (Suboxone) for treatment of opioid dependence. Previously available only for parenteral use in treatment of pain (Buprenex, and others), it offers an alternative to methadone (Dolophine, and others), which is now often abused (New York Times, February 9, 2003; page 1). As a schedule III narcotic, buprenorphine will be subject to fewer prescribing restrictions than a schedule II drug such as methadone (MJ Kreek and FJ Vocci, J Subst Abuse Treat 2002;...

Modafinil (Provigil - Cephalon; Alertec - Draxis in Canada), first approved by the FDA in 1999 for treatment of excessive daytime sleepiness associated with narcolepsy (Medical Letter 1999; 41:30), has now also been approved for treatment of patients with excessive sleepiness due to obstructive sleep apnea/hypopnea syndrome (OSAHS) or shift work sleep disorder (SWSD) (DSM-IV, text revision, Washington, DC: American Psychiatric Association, 2000, page 622).

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.

The US manufacturer of varicella zoster immune globulin (VZIG; Massachusetts Public Health Biologic Laboratories, Boston, MA) recently discontinued its production. A Canadian formulation, VariZIG (Varicella Zoster Immune Globulin [Human] - Cangene Corporation, Winnipeg) is now available in the US under an investigational new drug application expanded access protocol.