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目前分類:FDA 公告 (109)

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Companies failed to provide evidence of clinical benefit of midodrine hydrochloride

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2015-06-30-073123-1  

Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes

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Biosimilar-mAbs-may-have-tougher-time-in-US-FDA-says-expert_medium_vga  

The U.S. Food and Drug Administration today approved Zarxio (filgrastim-sndz), the first biosimilar product approved in the United States.

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Zerbaxa_Box_Angle_w_Vial  

The U.S. Food and Drug Administration today approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

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Tylenol-products-are-in-jeopardy  

最近因為一些案例,讓美國重新審視Acetaminophen還有鴉片類藥物的安全性

以下是Medscape和FDA的討論:

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螢幕快照 2014-01-24 8.16.28  

How is a medicine approved by FDA?

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xiaflex-peyronies-disease  

The U.S. Food and Drug Administration today approved a new use for Xiaflex (collagenase clostridium histolyticum) as the first FDA-approved medicine to treat men with bothersome curvature of the penis, a condition known as Peyronie’s disease.

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opsumit-for-rotator_503234_503237  

The US Food and Drug Administration (FDA) has approved macitentan (Opsumit, Actelion) to treat pulmonary arterial hypertension (PAH) in adults[1].

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MitraClip  

The US Food and Drug Administration(FDA) has approved the MitraClip (Abbott Vascular) for patients with symptomatic degenerative mitral regurgitation deemed high risk for mitral-valve surgery [1].

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The US Food and Drug Administration (FDA) today announced approved of flutemetamol F18 injection (Vizamyl, GE Healthcare), a radioactive diagnostic tracer for use with positron emission tomography (PET) of the brain in adults being evaluated for Alzheimer's disease (AD) and dementia.

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abraxane-Injection  

The US Food and Drug Administration (FDA) today approved nanoparticle albumin-bound (nab)-paclitaxel (Abraxane, Celgene), in combination with gemcitabine, for the first-line treatment of metastatic pancreatic cancer.

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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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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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