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 The drug was previously withdrawn from the market because of severe gastrointestinal toxicity.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).

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

Treprostinil sodium (tre prost' in il; Remodulin - United Therapeutics), a prostacyclin analogue, has been approved by the FDA for continuous subcutaneous (SC) treatment of patients with pulmonary arterial hypertension who have dyspnea on more than minimal exertion (NYHA Class II-IV).

Oxaliplatin (Eloxatin -Sanofi-Synthelabo) has been approved by the FDA for use in combination with fluorouracil (5-FU; Adrucil, and others) and leucovorin (LV; Wellcovorin) for patients with metastatic colorectal cancer whose disease has recurred or progressed despite treatment with 5-FU/LV plus irinotecan (Camptosar - Medical Letter 1997; 39:8).

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;...

Aripiprazole (Abilify - Bristol-Myers Squibb/Otsuka), a quinolinone derivative, has been approved by the FDA for treatment of schizophrenia.

Montelukast (Singulair - Merck), a leukotriene receptor antagonist already marketed for asthma (Treatment Guidelines from The Medical Letter 2002; 1:11), has been approved by the FDA for treatment of seasonal allergic rhinitis in adults and children more than 2 years old.

Adalimumab (Humira - Abbott), a tumor necrosis factor alpha (TNF-α) inhibitor, has been approved by the FDA for treatment of moderate to severe rheumatoid arthritis (RA). A genetically engineered human IgG1 monoclonal antibody, adalimumab is approved for subcutaneous (SC) injection in adults who have failed at least one disease-modifying anti-rheumatic drug (DMARD), for use either alone or with other DMARDs such as methotrexate (Rheumatrex, and others). Two other TNF-α antagonists, etanercept (Enbrel) and infliximab (Remicade), are already on the market for treatment of RA (Treatment...

Aprepitant (Emend - Merck), the first substance P/neurokinin 1 (NK₁) receptor antagonist to be approved by the FDA, is now available for oral use with corticosteroids and selective serotonin (5-HT₃) receptor antagonists to prevent nausea and vomiting caused by highly emetogenic anticancer drugs such as cisplatin.

Several recent case reports suggest that oral sildenafil may be effective for treatment of pulmonary arterial hypertension (PAH). Sildenafil is currently marketed as Viagra for treatment of erectile dysfunction (Medical Letter 1998; 40:51).