Voriconazole (Vfend -- Pfizer), an antifungal triazole structurally related to fluconazole (Diflucan) with a spectrum of action similar to that of itraconazole, has been approved by the FDA for primary treatment of invasive aspergillosis and for refractory infection with Scedosporium apiospermum (the asexual form of Pseudallescheria boydii) or Fusarium spp.

An injectable extended-release formulation of the opioid-receptor antagonist naltrexone (Vivitrol - Alkermes/Cephalon) has been approved by the FDA for once-monthly use, along with psychosocial support, to maintain abstinence from alcohol. Naltrexone inhibits the rewarding effects of alcohol. Oral naltrexone (Revia, and others) has been approved for treatment of alcohol dependence since 1994, but poor adherence has limited its effectiveness. In the new extended-release (XR) formulation, naltrexone is encapsulated in polylactide-co-glycolide microspheres (similar to absorbable suture material)...

Panitumumab (Vectibix - Amgen), a fully human IgG₂ monoclonal antibody that inhibits the epidermal growth factor receptor (EGFR), has been approved by the FDA for treatment of patients with EGFR-expressing metastatic colorectal cancer that has progressed despite standard chemotherapy. It is the second monoclonal antibody EGFR inhibitor to be approved for metastatic colorectal cancer; cetuximab (Erbitux), a human-murine chimeric IgG₁ monoclonal antibody, was approved in 2004.

Alemtuzumab (Campath), a genetically engineered, humanized monoclonal antibody currently approved to treat B-cell chronic lymphocytic leukemia (BCLL) and used off-label for induction therapy in solid organ transplants, is now also being tried off-label for treatment of relapsing multiple sclerosis (MS).

Seladelpar (Livdelzi – Gilead), a peroxisome proliferator-activated receptor (PPAR)-delta agonist, has received accelerated approval from the FDA for use in combination with ursodeoxycholic acid (ursodiol, UDCA; Urso Forte, and generics) for treatment of primary biliary cholangitis (PBC) in adults who had an inadequate response to UDCA and as monotherapy in those unable to tolerate UDCA. Accelerated approval was based on a reduction in alkaline phosphatase (ALP) levels. Seladelpar is the second PPAR agonist to be approved in the US for this indication; elafibranor (Iqirvo)...

Darunavir (Prezista - Tibotec), a new protease inhibitor, has received accelerated approval from the FDA for use in combination therapy of human-immunodeficiency virus (HIV) infection in previously treated adults. It is coadministered with low-dose ritonavir (Norvir), which increases its bioavailability.

Telaprevir (Incivek – Vertex) and boceprevir (Victrelis – Merck) have been approved by the FDA for oral use in combination with peginterferon and ribavirin for treatment of chronic hepatitis C virus (HCV) genotype 1 infection in adults with compensated liver disease. Both telaprevir and boceprevir were developed specifically to inhibit the NS3/4A proteases that cleave HCV encoded polyproteins of the genotype 1 virus.

A fixed-dose combination of atovaquone and proguanil hydrochloride has been approved by the FDA for oral prophylaxis and treatment of malaria due to Plasmodium falciparum, including choloroquine-resistant strains.

The FDA has approved the marketing of the corticosteroid ciclesonide (Alvesco - Sepracor) in a hydrofluoroalkane (HFA) metered-dose inhaler formulation for maintenance treatment of asthma in patients >12 years old. Ciclesonide is also available in the US as a nasal spray for allergic rhinitis (Omnaris), and has been available for asthma in Europe since 2003.

The FDA has approved the marketing of certolizumab pegol (Cimzia - UCB), a tumor necrosis factor (TNF) blocker, for treatment of moderate to severe Crohn's disease refractory to conventional treatment. It is the third TNF blocker approved for this indication.