FDA's Advisory Meetings（12月19日）
公開日時 2011/12/21 04:00
Recent and upcoming FDA advisory committee meetings and a summary of topics covered.
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Topic |
Advisory Committee |
Date |
| Columbia Labs and Watson Labs' Prochieve (progesterone vaginal gel 8%) for reduction of risk of preterm birth in women with short uterine cervical length |
Reproductive Health Drugs |
Jan. 20 |
| Pediatric-focused safety reviews under BPCA and PREA for Pfizer’s Prevnar 13 (pneumococcal 13-valent conjugate vaccine), GlaxoSmithKline’s Cervarix (human papillomavirus bivalent vaccine, recombinant), Novartis’ Focalin XR (dexmethylphenidate), Noven Pharms’ Daytrana (methylphenidate), AstraZeneca’s Seroquel (quetiapine), Janssen’s Pancreaze (pancrelipase), Aptalis Pharma’s Zenpep (pancrelipase), Abbott’s Creon (pancrelipase), Valeant’s Xerese cream 5%/1% (acyclovir/hydrocortisone), Genentech’s Xolair (omalizumab), Daiichi Sankyo’s Benicar (olmesartan), AstraZeneca’s Atacand (candesartan), Bayer’s Mirena (levonorgestrel-releasing intrauterine system), Duramed’s Plan B One Step (levonorgestrel), and Boehringer Ingelheim’s Flomax (tamsulosin) |
Pediatric |
Jan. 31 |
| NeurogesX Inc.'s Qutenza (capsaicin 8%) patch for management of neuropathic pain related to HIV-associated peripheral neuropathy |
Anesthetic and Analgesic Drug Products |
Feb. 9 |
| 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 the risk of infection |
Dermatologic and Ophthalmic Drugs |
Feb. 27
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