FDA's ANDA Approvals（4月6日）
公開日時 2012/04/13 04:00
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Advisory Committee |
Date |
| Astellas' mirabegron for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency |
Reproductive Health Drugs |
5-Apr |
| Pediatric safety reviews under BPCA and PREA for various drugs; update on FDA’s KidNet pilot study |
Pediatric |
7-May |
| Pediatric safety reviews under BPCA and PREA for various drugs |
Pediatric |
8-May |
| Regeneron Pharmaceuticals' Arcalyst (rilonacept) to prevent gout flares during initiation of uric acid-lowering therapy in adult patients with gout |
Arthritis |
8-May |
| Pfizer’s tofacitinib for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs |
Arthritis |
9-May |
| Gilead Sciences' Truvada (emtricitabine/tenofovir disoproxil fumarate) for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection |
Antiviral Drugs |
10-May |
| Arena Pharmaceuticals’ lorcaserin as an adjunct to diet and exercise for weight management in patients with a BMI ≥30 kg/m2 or ≥27 kg/m2 if accompanied by weight-related comorbidities |
Endocrinologic and Metabolic Drugs |
10-May |
| Gilead Sciences’ “Quad” combination tablet containing elvitegravir, cobicistat, emtricitabine and tenofovir, for treatment of HIV-1 in antiretroviral-naïve adults |
Antiviral Drugs |
11-May |
| Pfizer's Vyndaqel (tafamidis meglumine) to treat transthyretin familial amyloid polyneuropathy |
Peripheral and Central Nervous System Drugs |
24-May |
| Repligen's synthetic human secretin for use with MRI to improve pancreatic duct visualization for detection of duct abnormalities, to enhance clinical decision making in patients with known or suspected pancreatitis |
Gastrointestinal Drugs |
31-May
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（The Pink Sheet 4月9日号より） FDAと米国製薬企業の情報満載 “The Pink Sheet”はこちらから