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目前分類:FDA 公告 (116)

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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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Oxytrol  

The FDA has approved Oxytrol for Women, the first over-the-counter treatment for overactive bladder in women 18 and older.

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608px-Alogliptin.svg  

The US Food and Drug Administration has approved 3 different formulations of the selective dipeptidyl peptidase IV inhibitor alogliptin for the treatment of type 2 diabetes.

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adasuve  

The US Food and Drug Administration (FDA) has approved loxapine ( Adasuve , Alexza Pharmaceuticals) inhalation powder 10 mg for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

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varizig_vial  

The US Food and Drug Administration (FDA) today approved the varicella immune globulin preparation Varizig (Cangene) for reducing the severity of chickenpox infections in high-risk individuals when given within 4 days after exposure.

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200px-Bedaquiline.svg  

The US Food and Drug Administration (FDA) approved bedaquiline today as part of the treatment regimen for multidrug-resistant tuberculosis (MDR-TB) when other agents are unavailable.

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Eliquis    

The US Food and Drug Administration (FDA) has approved apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (AF).

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perampanel  

The US Food and Drug Administration (FDA) today announced approval of perampanel tablets (Fycompa, Eisai Inc) for treatment of partial-onset seizures in patients with epilepsy 12 years of age and older.

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ocriplasmin1  

The US Food and Drug Administration (FDA) yesterday approved ocriplasmin intravitreal injection (Jetrea, ThromboGenics, Inc) for the treatment of symptomatic vitreomacular adhesions (VMAs), the agency announced today.

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humira  

The US Food and Drug Administration (FDA) today approved adalimumab (Humira, Abbott Laboratories) for its seventh use: treating ulcerative colitis.

Adalimumab is now indicated for moderate to severe ulcerative colitis in adults who have not been helped by corticosteroids and other immunosuppressant medicines, the FDA stated in a press release today.

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120927053554-stivarga-packaging-story-top  

The US Food and Drug Administration (FDA) has approved the oral therapy regorafenib (Stivarga, Bayer) for the treatment of metastatic colorectal cancer.

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375px-Linaclotide.svg  

美國藥檢局核准新藥Linaclotide膠囊 (145ug) 上市,應用在原發性慢性便秘,以及大腸急躁症 (IBS) 合併便秘症。

The US Food and Drug Administration (FDA) approved the drug linaclotide (Linzess, Ironwood Pharmaceuticals) today for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation (IBS-C) in adults.

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index-img  

The US Food and Drug Administration (FDA) today approved bosutinib (Bosulif, Pfizer) as a new treatment option for adult patients with previously treated Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML).

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spotlight_logos_0004s_0000_aubagio  

The US Food and Drug Administration (FDA) has approved a second oral agent for the treatment of multiple sclerosis (MS), teriflunomide (Aubagio, Genzyme/Sanofi).

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kaletra tablet 01.jpg  

Lopinavir/ritonavir oral solution (Kaletra, Abbott Laboratories) should be avoided in premature or full-term infants for the first 14 days after their due dates because of possible cardiac, renal, or respiratory problems, the US Food and Drug Administration (FDA) announced today in a safety alert announcing a label change.

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makena_159108_159109.jpg  

The US Food and Drug Administration today approved hydroxyprogesterone caproate injection (Makena) to reduce the risk for preterm delivery before 37 weeks of pregnancy in women with singleton pregnancy and a history of at least 1 spontaneous preterm birth.

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