FDA actions

FDA actions

The FDA has approved the first new erythropoiesis-stimulating agent in more than 10 years. Peginesatide is approved to treat anemia associated with end-stage renal disease in patients on dialysis. The approval was based on two randomized, active-controlled, open-label trials which showed that the drug was as effective as epoetin in maintaining hemoglobin levels. The drug is not approved for chronic kidney disease patients who are not on dialysis or for cancer-related anemia. Peginesatide is marketed by Affymax Inc. as Omontys.

The FDA has approved the first generic ibandronate (Boniva), the popular once-monthly bisphosphonate to treat or prevent osteoporosis in postmenopausal women. Three companies have received approval to manufacture the drug including Apotex Inc., Orchid Healthcare, and Mylan Pharmaceuticals. The generic as well as the brand is dispensed with a medication guide regarding the possible risk of esophagitis, hypocalcemia, bone or muscle pain, osteonecrosis of the jaw, and atypical femoral fractures.

The FDA has also recently approved generic escitalopram (Lexapro), a selective serotonin reuptake inhibitor (SSRI) to treat adults with depression and generalized anxiety disorder. Teva Pharmaceuticals will be the first to market the generic in 5-, 10-, and 20-mg strengths. Like other SSRIs, escitalopram carries a box warning regarding increased risk of suicidal thinking and behavior in children, adolescents, and young adults.