目前分類：FDA 公告 (116)
- Jan 20 Fri 2012 07:53
- Dec 23 Fri 2011 07:11
Baxter International Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia A. ADVATE is the only antihemophilic factor approved in the United States for prophylactic use in both adults and children.
- Dec 20 Tue 2011 07:19
FDA核准 Jakafi 治療骨髓纖維化的藥物
The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis.
- Dec 18 Sun 2011 06:57
- Oct 11 Tue 2011 05:25
The US Food and Drug Administration (FDA) today approved tadalafil (Cialis, Eli Lilly), a phosphodiesterase-5 inhibitor, to also treat the signs and symptoms of benign prostatic hyperplasia (BPH) as well as a combination of BPH and erectile dysfunction (ED) when the conditions coincide.
- Sep 03 Sat 2011 08:37
The U.S. Food and Drug Administration (FDA) is warning the public that serious allergic reactions have been reported with the use of the antipsychotic medication Saphris (asenapine maleate). TheContraindications, Warnings and Precautions, Adverse Reactions, and Patient Counseling Informationsections of the Saphris drug label have been revised to include information about this risk and to inform healthcare professionals that Saphris should not be used in patients with a known hypersensitivity to the drug.
- Sep 01 Thu 2011 06:02
The US Food and Drug Administration has granted accelerated approval of brentuximab vedotin infusion (Adcetris, Seattle Genetics, Inc) for the treatment of relapsed or refractory Hodgkin's lymphoma and systemic anaplastic large cell lymphoma.
- Aug 28 Sun 2011 09:29
- Aug 27 Sat 2011 05:13
- Jun 30 Thu 2011 06:33
The US Food and Drug Administration (FDA) has approved nitroglycerin ointment 0.4% (Rectiv, ProStrakan Group) for the treatment of moderate to severe pain associated with chronic anal fissures, the company announced today.
- Jun 28 Tue 2011 03:24
- Jun 21 Tue 2011 06:01
The US Food and Drug Administration (FDA) approved ezogabine (Potiga, Valeant Pharmaceuticals and GlaxoSmithKline [GSK]) as an add-on medication to treat seizures associated with epilepsy in adults.
- Jun 19 Sun 2011 07:25
- Jun 13 Mon 2011 08:53
An FDA review launched in the wake of a controversial 2010 meta-analysis by DrIlke Sipahi (University Hospitals Case Medical Center, Cleveland, OH) et al  suggesting an increased risk of cancer among patients taking angiotensin-receptor blockers (ARBs) has concluded that the drugs do not pose a cancer risk to patients . But reacting to the FDA alert to heartwire , Sipahi said he was disappointed with how the FDA conducted its review and, in particular, its failure to do a patient-level analysis.
- Jun 10 Fri 2011 05:44
5-alpha reductase inhibitors（5-alpha 還原酶抑制劑）有可能會增加罹患前列腺癌的風險嗎？
On June 9, 2011, the U.S. Food and Drug Administration (FDA) informed the public of new safety information for drugs called 5-alpha reductase inhibitors (5-ARIs). Men who take these drugs may have an increased risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer). The Warnings and Precautions section of the labels for all FDA-approved 5-ARIs have been revised to include information about this risk.
- Jun 09 Thu 2011 08:48
The US Food and Drug Administration (FDA) announced today the approval of once-daily rilpivirine (Edurant, Tibotec Therapeutics, a division of Centocor Ortho Biotech Inc) for treatment of HIV infection. Rilpivirine is a nonnucleoside reverse transcriptase inhibitor (NNRTI) that may be taken once daily in combination with other antiretroviral drugs for HIV-infected, treatment-naive patients.