FDA's Advisory Meetings（８月24日）
公開日時 2009/08/27 04:00
| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| Discussion of bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products |
Pharmaceutical Science and Clinical Pharmacology Committees |
Aug. 4 |
| Committee will hear status updates from Office of Generic Drugs on bioequivalence for highly variable drugs, presentations from Office of Pharmaceutical Science on the scientific and regulatory challenges of transdermal drug delivery systems, and other issues |
Pharmaceutical Science and Clinical Pharmacology Committees |
Aug. 5 |
| GE Healthcare's radiopharmaceutical DaTSCAN (ioflupane I 123 injection) for a special type of brain imaging in patients with movement disorders |
Peripheral and Central Nervous System Drugs |
Aug. 11 |
| Amgen's Prolia (denosumab) for treatment and prevention of osteoporosis in postmenopausal women, and for treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer |
Reproductive Health Drugs |
Aug. 13 |
| Genzyme's Clolar (clofarabine) injection for added indication of acute myeloid leukemia in patients over age 60 with at least one unfavorable prognostic factor; Vion's Onrigin (laromustine) injection for remission induction in patients over 60 with de novo poor-risk AML |
Oncologic Drugs |
Sept. 1 |
| Goucester's Istodax (romidepsin) for cutaneous T-cell lymphoma, including relief of pruritus; Allos Therapeutics' Folotyn (pralatrexate) for relapsed or refractory peripheral T-cell lymphoma |
Oncologic Drugs |
Sept. 2 |
| GlaxoSmithKline's Human Papillomavirus vaccine for use in females, and Merck's HPV vaccine Gardasil for use in males |
Vaccines and Related Biological Products |
Sept. 9 |
| Auxilium Pharmaceuticals' BLA for clostridial collagenase for advanced Dupuytren's disease |
Arthritis Drugs |
Sept. 16 |
| Neuromed's Exalgo (modified-release hydromorphone) for moderate to severe pain in opioid-tolerant patients |
Anesthetic Life Support Drugs and Drug Safety and Risk Management Committees |
Sept. 23 |
| Pfizer's Selzentry (maraviroc) for supplemental indication to treat antiretroviral-naïve patients with chemokine (c-c motif) receptor 5 (CCR5) tropic human immunodeficiency virus |
Antiviral Drugs |
Oct. 8 |
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