Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Meeting

Joint Meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Meeting Committee Meeting March 5, 2013 8:00 a.m. to 4:00 p.m. Agenda: The committees will discuss whether the benefit of calcitonin salmon for the treatment of postmenopausal osteoporosis (thinning and weakening of bones that increases the chance of having a broken bone) outweighs a potential risk of cancer. Calcitonin salmon products approved for the treatment of osteoporosis include Miacalcin (calcitonin salmon) injection and nasal spray, submitted by Novartis Pharmaceuticals Corporation; Fortical (calcitonin salmon recombinant) nasal spray, Upsher Smith Laboratories; and the generic equivalents of these products.