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目前分類:FDA 公告 (111)

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frame1  

The US Food and Drug Administration (FDA) yesterday approved the first recombinant coagulation factor IX (Rixubis, Baxter Healthcare) for the routine prevention of bleeding in patients with hemophilia B who are 16 years of age and older, the agency announced.

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Xofigo_Case-Upright-Syringe  

A novel radiopharmaceutical agent has been approved by the US Food and Drug Administration (FDA) for use in the treatment of prostate cancer.

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Exelon-Patch  

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.

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golimumab  

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。

之前也有跟各位提過這個藥物:

Simponi (golimumab)

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.

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vemurafenib   

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.

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w460  

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).

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ilarisv-30763_1  

The US Food and Drug Administration (FDA) has approved canakinumab (Ilaris, Novartis) to treat active systemic juvenile idiopathic arthritis (JIA) in patients aged 2 years and older, the manufacturer announced today.

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procysbi  

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.

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Liptruzet%2021  

Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved LIPTRUZET™(ezetimibe and atorvastatin) tablets for the treatment of elevated low-density lipoprotein (LDL) cholesterol in patients with primary or mixed hyperlipidemia as adjunctive therapy to diet when diet alone is not enough. LIPTRUZET (pronounced LIP-true-zett) contains ezetimibe, an efficacious LDL cholesterol lowering therapy, and atorvastatin, currently one of the most widely prescribed statins in the U.S.[1] Once-daily LIPTRUZET treats  two sources of cholesterol by inhibiting both the absorption of cholesterol in the digestive tract – through ezetimibe – and the production of cholesterol in the liver – through atorvastatin. 

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plan-b-contraception-4_3_r536_c534  

聯邦食品暨藥物管理局(FDA)30日宣布,15歲及以上的婦女在購買事後避孕丸「B計畫」(Plan B One-Step)時,不需要處方。FDA是在法院下令該局須在5月6日前取消「B 計畫」購買年齡限制的前數日,做出此決定。

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amitiza-02amitiza  

FD核准Amitiza用來治療鴉片類引起的便秘

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.

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OxyContin-addiction-statistics2  

The US Food and Drug Administration (FDA) today approved updated labelling for the abuse-deterrent formulation of oxycodone hydrochloride controlled-release tablets (OxyContin, Purdue Pharma LP).

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logo-diclegis-header  

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.

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cataract  

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.

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220px-Carbinoxamine.svg  

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.

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011169596  

The US Food and Drug Administration (FDA) has approved long-acting aripiprazole (Abilify Maintena, Otsuka/Lundbeck) for the maintenance treatment of adults with schizophrenia.

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289319  

FDA核准Osphena使用在中度至重度的停經後的性交疼痛

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.

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regorafenib-product  

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.

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Uceris  

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.

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7939626.bin  

The oral therapy pomalidomide (Pomalyst, Celgene) was approved by the US Food and Drug Administration today for use in the treatment of multiple myeloma.

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