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.

Reproductive Health Drugs Advisory Committee Meeting

Reproductive Health Drugs Advisory Committee Meeting Committee Meeting March 4, 2013 8:00 a.m. to 5:00 p.m. Agenda : On March 4, 2013, during the morning session, the committee will discuss new drug application (NDA) 022506, gabapentin 600 milligram (mg) tablets, submitted by Depomed, Inc., for the proposed indication of treatment of moderate to severe vasomotor symptoms due to menopause. During the afternoon session, the committee will discuss NDA 204516, paroxetine mesylate 7.5 mg capsules, submitted by Noven Therapeutics, LLC, for the proposed indication of treatment of moderate to severe vasomotor symptoms associated with menopa

Medical Imaging Drugs Advisory Committee

Medical Imaging Drugs Advisory Committee Committee Meeting February 14, 2013 8:00 a.m. to 3:00 p.m. Agenda: The committee will discuss new drug application (NDA) 204781, proposed trade name DOTAREM (gadoterate meglumine injection), application submitted by Guerbet, LLC. The proposed indication (use) for this product is for magnetic resonance imaging in brain (intracranial), spine, and associated tissues in adults and pediatric patients (from neonates to 17 years of age) to detect and visualize areas with disruption of the blood brain barrier (specialized tissues that help protect the brain) and/or abnormal vascularity (abnormal blood circulation).