Fluoxetine (Prozac - Dista), a phenylpropylamide, is the first serotonin-reuptake blocker introduced in the USA for treatment of . It is being promoted as causing fewer adverse effects than other antidepressants. Claims of greater safety and patient tolerability have often been made for new non-tricyclic antidepressants in recent years, but unpredicted adverse effects have emerged with widespread use, including priapism with trazodone (Desyrel - Medical Letter, 26:35, 1984) and fatal hemolytic anemia with nomifensine (Merital - Medical Letter, 27:73, 1985).

Famciclovir (Famvir - SmithKline Beecham) is now available in the USA for oral treatment of acute uncomplicated herpes zoster (shingles). The manufacturer claims that use of the drug reduces the duration of postherpetic neuralgia. Famciclovir is similar to acyclovir (Zovirax - Burroughs Wellcome), which has been the drug of choice for treatment of varicella-zoster and herpes simplex virus infections (Medical Letter, 36:27, 1994).

Bexarotene, a retinoid analog, has been approved by the US Food and Drug Administration for oral treatment of dermatologic manifestations of refractory cutaneous T-cell lymphoma.

Formoterol fumarate inhalation powder Foradil Aerolizer, a long-acting beta2-adrenergic receptor agonist, has been approved by the FDA for maintenance treatment of asthma and prevention of exercise-induced bronchospasm. The drug has been available in Europe for many years.

The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (Jevtana – Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel (Taxotere).

The injectable direct thrombin inhibitor desirudin (Iprivask – Canyon), a recombinant analog of hirudin, the leech anticoagulant protein, was approved by the FDA in 2003 for prevention of venous thromboembolism (VTE) after elective hip arthroplasty, but was only marketed recently in the US. It has been available in Europe as Revasc for about 10 years. Two other hirudin analogs are available in the US: lepirudin (Refludan) for treatment of heparin-induced thrombocytopenia (HIT) and bivalirudin (Angiomax) for use in percutaneous coronary intervention (PCI).

The FDA has approved a once-weekly extendedrelease formulation of exenatide (Bydureon – Amylin), an injectable glucagon-like peptide-1 (GLP-1) receptor agonist, for treatment of type 2 diabetes.

The FDA has approved the interleukin-1 (IL-1) beta inhibitor canakinumab (Ilaris – Novartis) for treatment of systemic juvenile idiopathic arthritis (sJIA; formerly called juvenile rheumatoid arthritis or Still’s disease) in children ≥2 years old. Canakinumab was approved earlier for treatment of cryopyrin-associated periodic syndromes (CAPS). Tocilizumab (Actemra), an interleukin-6 (IL-6) inhibitor that has been available since 2010 for treatment of rheumatoid arthritis in adults, was also recently approved by the FDA for sJIA. Canakinumab is the only IL-1 inhibitor approved...

Two new extended-release amphetamine products have been approved by the FDA for once-daily treatment of attention-deficit/hyperactivity disorder (ADHD) in patients ≥6 years old: Adzenys XR-ODT (Neos Therapeutics), an orally distintegrating tablet, and Dyanavel XR (Tris Pharma), an oral suspension.

Deflazacort (Emflaza – PTC Therapeutics), an oral corticosteroid, has been approved by the FDA for treatment of Duchenne muscular dystrophy (DMD) in patients ≥5 years old. It has been available outside the US for many years. Deflazacort is the second drug to be approved for treatment of DMD; eteplirsen (Exondys 51), an antisense oligonucleotide approved for IV administration in patients with mutations of the dystrophin gene amenable to exon 51 skipping (about 13% of DMD cases), was the first.