FDA's Advisory Meetings（2月13日）
公開日時 2012/02/17 04:00
| Topic |
Advisory Committee |
Date |
| Vivus’ Qnexa (phentermine/topiramate) as an adjunct to diet and exercise for weight management in patients with a BMI greater than or equal to 30 kg/m2 or a BMI greater than or equal to 27 kg/m2 if accompanied by weight-related comorbidities |
Endocrinologic and Metabolic Drugs |
Feb. 22 |
| Chelsea Therapeutics’ Northera (droxidopa) for symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency and Non-Diabetic Autonomic Neuropathy |
Cardiovascular and Renal Drugs |
Feb. 23 |
| Forest Laboratories' aclidinium bromide for long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema |
Pulmonary-Allergy Drugs |
Feb. 23 |
| Appropriate clinical evidence for developing anti-inflammatory drugs to treat postoperative inflammation and reduction of eye pain in patients who have undergone ocular surgery, and the appropriateness of marketing a single bottle of ophthalmic product, such as Ista Pharmaceuticals' Bromday (bromfenac ophthalmic solution 0.09%), for use in both eyes post-surgery, given risk of infection |
Dermatologic and Ophthalmic Drugs |
Feb. 27 |
| Overview of the research program in the Laboratory of Mycobacterial Diseases and Cellular Immunology; selection of strains to be included in the influenza virus vaccine for the 2012-2013 influenza season |
Vaccines and Related Biological Products |
Feb. 28 |
| Licensure pathways for pandemic influenza vaccines |
Vaccines and Related Biological Products |
Feb. 29 |
| Development of anti-nerve growth factor drugs, including safety issues such as whether reports of joint destruction represent a safety signal and whether the risk-benefit balance favors continued development of these drugs as analgesics |
Arthritis |
12-Mar |
| Appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia in newborns |
Gastrointestinal Drugs |
13-Mar |
| Clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development |
Pharmaceutical Science and Clinical Pharmacology |
14-Mar |
| GlaxoSmithKline's Votrient (pazopanib) for patients with advanced soft tissue sarcoma who have received prior chemotherapy |
Oncologic Drugs |
20-Mar |
| Merck Sharp & Dohme's Taltorvic (ridaforolimus) for metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least four cycles of chemotherapy without evidence of disease progression |
Oncologic Drugs |
20-Mar |
| Talon Therapeutics’ Marqibo (vincristine sulfate liposomes injection) for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy |
Oncologic Drugs |
21-Mar |
| The role of cardiovascular assessment in the pre- and post-approval settings for obesity drugs and biologics |
Endocrinologic and Metabolic Drugs |
March 28-29 |
| Astellas' mirabegron for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency |
Reproductive Health Drugs |
5-Apr |
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