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目前分類:FDA 公告 (118)

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The US Food and Drug Administration (FDA) has approved two new oral treatments for adults with HIV-1 infection, Pifeltro and Delstrigo, both from Merck & Co, according to a company news release.

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Achaogen Inc said on Tuesday U.S. health regulators cleared its antibiotic Zemdri (plazomicin) to treat adults with complicated urinary tract infections, but declined approval for treating bloodstream infections.

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The US Food and Drug Administration (FDA) has approved sodium zirconium cyclosilicate (Lokelma, AstraZeneca) — a medication that rapidly restores normal potassium levels — for adults with hyperkalemia.

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The US Food and Drug Administration (FDA) has expanded the use of the inhaled corticosteroid fluticasone furoate (Arnuity Ellipta, GlaxoSmithKline) as a once-daily asthma maintenance treatment for children as young as age 5 years.

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The US Food and Drug Administration (FDA) has approved estradiol vaginal inserts (Imvexxy, TherapeuticsMD) for women with moderate to severe dyspareunia (vaginal pain during sex) resulting from menopause.

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Healthcare providers should exercise caution when prescribing the macrolide antibiotic clarithromycin (Biaxin, generics) to patients with coronary heart disease because of a potential increased risk for heart problems or death that can occur years later, the US Food and Drug Administration (FDA) said today in a safety communication.

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Merck Receives FDA Approval of PREVYMIS™ (letermovir) for Prevention of Cytomegalovirus (CMV) Infection and Disease in Adult Allogeneic Stem Cell Transplant Patients

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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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