目前分類：FDA 公告 (110)
- Jun 24 Mon 2013 05:26
- Jun 06 Thu 2013 08:17
The US Food and Drug Administration has approved an expanded indication for the rivastigmine transdermal system (Exelon Patch, Novartis Pharmaceuticals Corporation) to include patients with severe disease.
- Jun 04 Tue 2013 07:58
fda核准 Simponi (golimumab) 注射劑的新的用法在成人中度與重度潰瘍性結腸炎。
The US Food and Drug Administration (FDA) today approved a new indication for the tumor necrosis factor (TNF)-alpha inhibitor golimumab (Simponi, Janssen Biotech): treatment of adults with moderate to severe ulcerative colitis that is resistant to prior treatment or requires continuous steroid therapy.
- Jun 03 Mon 2013 23:59
Two new drugs have been approved by the US Food and Drug Administration (FDA) for use in certain patients with metastatic or unresectable melanoma, along with a diagnostic test to identify patients who are suitable for treatment.
- May 18 Sat 2013 05:09
The US Food and Drug Administration (FDA) gave the marketing nod today to a novel once-daily inhaled therapy for the treatment of chronic obstructive pulmonary disease (COPD).
- May 15 Wed 2013 10:03
- May 08 Wed 2013 08:22
The US Food and Drug Administration (FDA) today approved a delayed-release version of cysteamine bitartrate (Procysbi, Raptor Pharmaceuticals) for a rare genetic disorder called nephropathic cystinosis, the agency announced.
- May 03 Fri 2013 08:26
- Apr 23 Tue 2013 04:36
The US Food and Drug Administration (FDA) has approved lubiprostone (Amitiza, Sucampo Pharmaceuticals Inc/Takeda Pharmaceuticals USA Inc), the first oral treatment for opioid-induced constipation in adults with chronic noncancer pain.
- Apr 15 Mon 2013 09:16
- Apr 12 Fri 2013 07:30
The US Food and Drug Administration (FDA) today approved the combination of doxylamine and pyridoxine (Diclegis, Duchesnay) to treat pregnant women with nausea and vomiting who have not adequately responded to dietary and lifestyle changes, the agency has announced.
- Apr 09 Tue 2013 07:57
Today the Food and Drug Administration (FDA) approved a new formulation of a once-daily nonsteroidal anti-inflammatory drug (NSAID) for the treatment of postoperative pain and inflammation in patients who have undergone cataract surgery. The newly approved 0.7% bromfenac ophthalmic solution (Prolensa, Bausch + Lomb) will likely replace the currently available 0.9% bromfenac ophthalmic solution.
- Apr 03 Wed 2013 10:45
The US Food and Drug Administration (FDA) has approved carbinoxamine maleate extended-release (Karbinal ER, Tris Pharma), the first liquid, sustained-release histamine-H1 receptor blocker indicated for the treatment of seasonal and perennial allergic rhinitis in children aged 2 years and older, the company said.
The drug will be available in a 4 mg/5 mL oral suspension.
- Feb 27 Wed 2013 08:17
The US Food and Drug Administration (FDA) has approved ospemifene (Osphena, Shionogi, Inc) for treating moderate to severe dyspareunia in postmenopausal women, the agencyannounced today.
- Feb 26 Tue 2013 09:54
The indication for the oral targeted agent regorafenib (Stivarga, Bayer) has been expanded by the US Food and Drug Administration (FDA); it is now approved for the treatment of gastrointestinal stromal tumors (GIST). Specifically, it is indicated for use in patients with tumors that cannot be surgically removed and no longer respond to imatinib (Gleevec) and sunitinib (Sutent), the 2 other FDA-approved treatments for this disease.
- Feb 21 Thu 2013 05:53
The US Food and Drug Administration (FDA) has approved budesonide extended release tablets (Uceris, Santarus) for the treatment of active mild to moderate ulcerative colitis in adult patients, the manufacturer announced January 16.
- Feb 08 Fri 2013 09:53