Paliperidone (Invega - Janssen) has been approved by the FDA in an extended-release formulation for treatment of schizophrenia. It is the primary active metabolite of the second-generation antipsychotic risperidone (Risperdal - Janssen), which is scheduled to lose its patent exclusivity in December 2007.

Golimumab (Simponi - Centocor), a fully humanized anti-tumor necrosis factor (TNF)-a antibody, has been approved by the FDA for the treatment of: (1) moderate to severe active rheumatoid arthritis (RA) in combination with methotrexate; (2) active psoriatic arthritis (PsA) alone or in combination with methotrexate; and (3) active ankylosing spondylitis (AS).

The FDA has approved tenapanor (Ibsrela - Ardelyx), a sodium/hydrogen exchanger 3 (NHE3) inhibitor, for twice-daily oral treatment of irritable bowel syndrome with constipation (IBS-C) in adults. Tenapanor is the first NHE3 inhibitor to become available in the US.

Bexagliflozin (Brenzavvy – TheracosBio), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved by the FDA to improve glycemic control in adults with type 2 diabetes. It is the fifth SGLT2 inhibitor to be approved in the US for this indication (see Table 4).

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).

Colesevelam hydrochloride (Welchol - Sankyo Pharma), a nonabsorbed hydrophilic polymer that binds bile acids, has been approved by the FDA for reduction of plasma LDL cholesterol in patients with primary hypercholesterolemia.

Balsalazide disodium (Colazal), a prodrug of mesalamine, was marketed in the US this year for oral treatment of mildly to moderately active ulcerative colitis. Oral formulations of mesalamine have been available in the US for nine years for treatment and maintenance of remissions and olsalazine, which is a dimer of mesalamine, is marketed for maintenance of remissions but not for treatment. Balsalazide has been available in Europe for four years.

The FDA has approved the HMG-CoA reductase inhibitor (statin) pitavastatin magnesium (Zypitamag – Zydus) for use in adults with primary hyperlipidemia or mixed dyslipidemia. The FDA considers pitavastatin magnesium bioequivalent to pitavastatin calcium (Livalo), which was approved in 2009.1Statins remain the treatment of choice for most patients who require lipid-lowering therapy. Taken as an adjunct to diet modification, increased exercise, and smoking cessation, statins can reduce the risk of primary and secondary cardiovascular events and death in patients with or at high risk for...

Two new drugs alendronate (Fosamax - Merck) and salmon calcitonin nasalspray (Miacalcin - Sandoz) are now available in the USA for treatment of postmenopausalosteoporosis. A third drug for treatment of osteoporosis, a slow-release fluoridepreparation (Slow Fluoride -Mission Pharmacal), has been recommended for approvalby an advisory committee of the US Food and Drug Administration (FDA). Various formulationsof fluoride have been available in Europe for this indication for many years.

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.