Disease relevance of United States Food and Drug Administration

• BACKGROUND: The Food and Drug Administration (FDA) has recommended that cereal-grain products be fortified with folic acid to prevent congenital neural-tube defects [1].
• The Food and Drug Administration documents the receipt of 12 case reports of severe myopathy or rhabdomyolysis associated with concomitant use of lovastatin and gemfibrozil, including 10 voluntary postmarketing, and 2 required, reports [2].
• CONCLUSIONS--Three years after Food and Drug Administration approval and Medicare coverage of EPO, there was no evidence of racial disparity in access to EPO among Medicare patients with ESRD who were receiving long-term hemodialysis [3].
• The National Heart, Lung and Blood Institute, Bethesda, Md, and the Food and Drug Administration, Washington, DC, sponsored two national probability telephone surveys (N = 4000) of adults to assess attitudes and knowledge about heart disease risk from high blood cholesterol levels and the public's efforts to lower blood cholesterol levels [4].
• CONTEXT: Tissue-type plasminogen activator (tPA) is the only therapy for acute ischemic stroke approved by the Food and Drug Administration. OBJECTIVE: To assess the safety profile and to document clinical outcomes and adverse events in patients treated with intravenous tPA for acute stroke in clinical practice [5].

Psychiatry related information on United States Food and Drug Administration

• The National Surgical Adjuvant Breast and Bowel Project (NSABP) P-1: Breast Cancer Prevention Trial (BCPT) demonstrated the superiority of the SERM tamoxifen to placebo in reducing breast cancer risk, leading to the Food and Drug Administration approval of tamoxifen for risk reduction [6].
• After reviewing the efficacy and safety of bupropion sustained release (SR) as an agent for treating smoking cessation, the Food and Drug Administration recently approved the use of bupropion SR for this indication [7].
• BACKGROUND: Modafinil is a novel wake-promoting agent that has U.S. Food and Drug Administration approval for narcolepsy and shift work sleep disorder and as adjunctive treatment of obstructive sleep apnea/hypopnea syndrome [8].
• The Food and Drug Administration approved the use of buspirone for generalized anxiety disorder (GAD) in 1986 [9].
• Emerging clinical data favor the SSRIs as first-line treatment for patients with panic disorder, and paroxetine and sertraline have been approved by the U.S. Food and Drug Administration for use in panic disorder [10].

High impact information on United States Food and Drug Administration

• The only nonnicotine medication that has been approved by the US Food and Drug Administration is bupropion [11].
• Albendazole is a new, broad-spectrum antiparasitic drug, which was approved recently by the Food and Drug Administration. International trials have shown albendazole to be safe and effective in eradicating many parasites [12].
• BACKGROUND: Fenfluramine and phentermine have been individually approved as anorectic agents by the Food and Drug Administration (FDA) [13].
• Although thrombolysis with tissue plasminogen activator (tPA) is a stroke therapy approved by the US Food and Drug Administration, its efficacy may be limited by neurotoxic side effects [14].
• Tuna samples (available from 3 outbreaks) had histamine levels above the Food and Drug Administration regulatory level of 50 ppm (levels were between 213 and 3245 ppm) [15].

Chemical compound and disease context of United States Food and Drug Administration

• The U.S. Food and Drug Administration (FDA) subsequently approved tamoxifen for women aged 35 years or older with a 5-year breast cancer risk of 1.67% or higher for breast cancer chemoprevention [16].
• Phase III trials in esophageal cancer and lung cancer are in progress and will help in evaluation of whether Photofrin II, the most widely used sensitizer, can be added to the oncologic armamentarium, pending approval from the U.S. Food and Drug Administration [17].
• METHODS: From 338 reports submitted to the Food and Drug Administration, 247 were considered inadequate or unconvincing for sulindac toxicity [18].
• DATA SOURCES: Medical records, published case reports, and case reports submitted to the U.S. Food and Drug Administration. STUDY SELECTION: Instances of ticlopidine-associated thrombotic thrombocytopenic purpura were identified [19].
• Bleomycin was approved by the Food and Drug Administration in 1975 for therapy against squamous cell carcinomas, testicular cancers, and malignant lymphomas [20].

Biological context of United States Food and Drug Administration

• The Food and Drug Administration has several options that will assist the Public Health Service in implementing its September 1992 recommendation that all women of childbearing age consume 0.4 mg folic acid daily to reduce their risk of having a pregnancy affected with a neural tube defect [21].
• PARTICIPANTS: Four hundred fifty-two patients with best spectacle-corrected visual acuity of 20/20 or better and myopia (1.0-3.5 diopters [D]) were enrolled in the U.S. Food and Drug Administration clinical trials of INTACS [22].
• Pentoxifylline, a hemorrheologic agent that lowers whole blood viscosity by increasing red cell membrane deformability, recently was approved by the Food and Drug Administration for the treatment of intermittent claudication [23].
• OBJECTIVES: To review the concept of remission in rheumatoid arthritis (RA), as defined by the Food and Drug Administration (FDA), the American College of Rheumatology (ACR), and the European League Against Rheumatism (EULAR) [24].
• After a sudden recurrence of seizures when generic valproic acid was substituted for the brand-name product, an investigation by the US Food and Drug Administration found a difference in bioavailability between the 2 formulations [25].

Anatomical context of United States Food and Drug Administration

• Marketing approval was granted by the US Food and Drug Administration on November 26, 1997 (and by the European Union on June 2, 1998) for the indication of relapsed or refractory, CD20-positive, B-cell, low-grade or follicular non-Hodgkin's lymphoma [26].
• Albendazole therapy was delayed and may have been too late to prevent bile duct damage; the drug had to be approved by the US Food and Drug Administration for compassionate use [27].
• Trimethoprim recently has been released by the Food and Drug Administration (FDA) exclusively for the treatment of acute symptomatic uncomplicated bacterial urinary tract infections [28].
• Intrathecally administered baclofen has been approved by the Food and Drug Administration (FDA) for the treatment of spasticity in patients with spinal cord injury who are refractory to or cannot tolerate oral baclofen [29].
• Therapeutic options for intractable epilepsy include new and investigational antiepileptic drugs, ketogenic diet, epilepsy surgery, and, now, vagus nerve stimulation, which is approved by the U.S. Food and Drug Administration for the treatment of refractory partial seizures in adolescents and adults [30].

Associations of United States Food and Drug Administration with chemical compounds

• The US Food and Drug Administration authorized addition of folic acid to enriched grain products in March 1996, with compliance mandatory by January 1998 [31].
• From the Food and Drug Administration. Update on zidovudine [32].
• CONCLUSIONS: The 4 generic and brand-name levothyroxine preparations studied are different but are bioequivalent by current Food and Drug Administration criteria and are interchangeable in the majority of patients receiving thyroxine replacement therapy [33].
• Contraindicated use of cisapride: impact of food and drug administration regulatory action [34].
• Nitrates, package inserts, and the Food and Drug Administration. A clinical paradox [35].

Gene context of United States Food and Drug Administration

• Thus far, two of these agents, both of which neutralize tumor necrosis factor alpha (TNF-alpha), have received US Food and Drug Administration approval for the treatment of the disease [36].
• Etanercept, recombinant p75 sTNFR:Fc fusion protein, has received approval from the US Food and Drug Administration for patients with RA and juvenile RA (JRA) who have failed treatment with at least one other drug [37].
• Interleukin-2 (IL-2) recently was approved by the Food and Drug Administration for the treatment of renal cell cancer [38].
• In the last 2 years, the U.S. Food and Drug Administration and the European Union's Commission of the European Communities have approved two biological agents for the treatment of refractory RA, etanercept and infliximab [39].
• Cetuximab, a monoclonal EGFR antibody, has shown efficacy in combination with radiotherapy in advanced SCCHN in a recent phase III trial and is currently being petitioned for US Food and Drug Administration approval [40].

Analytical, diagnostic and therapeutic context of United States Food and Drug Administration

• Specific leukotriene receptor antagonists and synthesis inhibitors have been developed and are currently showing promise in clinical trials; one leukotriene receptor antagonist (zafirlukast) and one 5-lipoxygenase inhibitor (zileuton) were recently approved by the United States Food and Drug Administration for the treatment of asthma [41].
• On May 5, 2003, gefitinib (Iressa; ZD1839) 250-mg tablets (AstraZeneca Inc.) received accelerated approval by the United States Food and Drug Administration as monotherapy for patients with locally advanced or metastatic non-small cell lung cancer after failure of both platinum-based and docetaxel chemotherapies [42].
• The first milestone in drug development of cysteine protease inhibitors has probably been reached, as IDN-6556 (a broad spectrum caspase inhibitor) has recently received Orphan Drug label by the U.S. Food and Drug Administration for use in the treatment of the patients undergoing liver transplantation and other solid organ transplantation [43].
• Our study was designed to determine whether the COX-2 inhibitor celecoxib could be safely administered in doses within those approved by the Food and Drug Administration when used concurrently with thoracic radiotherapy in patients with poor prognosis non-small cell lung cancer (NSCLC) [44].
• OBJECTIVE: We sought to study the predictive value of available Food and Drug Administration (510K)-cleared latex-specific IgE antibody immunoassays in the diagnosis of latex allergy [45].

References