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目前分類:FDA 公告 (118)

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rosaceapapules  

The US Food and Drug Administration (FDA) has approved brimonidine topical gel 0.33% (Mirvaso, Galderma Laboratories) for facial redness resulting from rosacea in adults aged 18 years or older, the company announced today.

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tivicay_web_435852_435853  

The US Food and Drug Administration (FDA) today approved a new drug called dolutegravir (Tivicay, GlaxoSmithKline) as an adjunct to other antiretroviral drugs that treat individuals infected with HIV-1, the agency announced.

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Fetzima  

The US Food and Drug Administration has approved levomilnacipran (Fetzima, Forest Laboratories, Inc.), a new serotonin-norepinephrine reuptake inhibitor (SNRI), for major depressive disorder (MDD) in adults, making the drug the fourth SNRI to be approved in the United States.

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Zubsolv-packaging  

The US Food and Drug Administration (FDA) has approved Zubsolv (buprenorphine/naloxone, Orexo AB) for maintenance treatment of opioid dependence.

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Simponi  

上次也跟各位提過這個藥物:

[Medscape][FDA Approvals]FDA Approves New Indication for Simponi

The US Food and Drug Administration (FDA) has approved golimumab (Simponi Aria, Janssen Biotech, Inc), intravenous (IV) formulation in combination with methotrexate, for the treatment of moderately to severely active rheumatoid arthritis (RA), the company has announced today.

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Slide03  

A new targeted therapy, afatinib (Gilotrif, Boehringer Ingelheim), has been approved by the US Food and Drug Administration (FDA) for use in the treatment of metastatic nonsmall-cell lung cancer (NSCLC) that tests positive for epidermal growth-factor receptor mutations (EGFRm+). A companion diagnostic test, the Therascreen EGFR PCR Kit(from Qiagen), has been approved at the same time.

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Brisdelle  

The first nonhormonal drug for hot flashes associated with menopause was approved by the US Food and Drug Administration (FDA) today despite an agency advisory committee having rejected it as too much risk for minimal benefit.

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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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