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...

The FDA recently announced that it will permit reintroduction of alosetron hydrochloride (Lotronex - GlaxoSmithKline) for treatment of irritable bowel syndrome (IBS). The drug was previously withdrawn from the market because of severe gastrointestinal toxicity. The reintroduced drug will have a 50% lower starting dose, a narrower indication and some other marketing restrictions (www.fda.gov/cder/drug/infopage/lotronex/lotronex.htm).

Tiotropium bromide inhalation powder (Spiriva HandiHaler - Boehringer Ingelheim), a long-acting anticholinergic agent, has been approved by the FDA for once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). Available in Europe since 2002, it is the first long-acting inhaled anticholinergic drug for treatment of COPD. Ipratropium bromide (Atrovent), an anticholinergic used four times daily, has been available in the US for many years.

The FDA has approved Exforge (Novartis) and Azor (Daiichi Sankyo), the first combinations of a calcium channel blocker (CCB) with an angiotensin receptor blocker (ARB) for treatment of hypertension. Amlodipine is the CCB in both products. The ARBs are valsartan in Exforge and olmesartan in Azor. All 3 of these drugs are available in fixed-dose combinations with other antihypertensive drugs.

The FDA has approved the marketing of a second fixed-dose combination of extended-release niacin (Niaspan) with a generic statin. Niaspan/simvastatin (Simcor - Abbott) is approved for use in patients with hypercholesterolemia or mixed dyslipidemia (high LDL-cholesterol, low HDL-cholesterol and high serum triglycerides). Niaspan/lovastatin (Advicor) was marketed previously for the same indications.

Since publication of our recent article on antiviral drugs for influenza, increased levels of resistance to oseltamivir (Tamiflu) have been detected in influenza A H1N1 strains.

The FDA has approved five tumor necrosis factor (TNF) inhibitors for treatment of moderately to severely active rheumatoid arthritis (RA). TNF-α is a pro-inflammatory cytokine involved in the pathogenesis of many systemic inflammatory disorders.

Armodafinil (Nuvigil – Cephalon), the R-enantiomer of the non-amphetamine stimulant modafinil (Provigil – Cephalon; Alertec – Shire in Canada), is being promoted directly to the public for treatment of excessive daytime sleepiness associated with shift work.

The FDA has approved the mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor cobimetinib (Cotellic – Genentech) for use in combination with the BRAF kinase inhibitor vemurafenib (Zelboraf) for treatment of unresectable or metastatic melanoma with a BRAF V600E or V600K mutation.

The FDA has approved fostamatinib disodium hexahydrate (Tavalisse – Rigel), the first spleen tyrosine kinase (SYK) inhibitor, for oral treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.