Books: 'FDA-approved drug'

1

United States. Food and Drug Administration, ed. FDA Approved Animal Drug Products, 1998. [S.l: s.n., 1998.

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2

United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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3

R, Loughlin Kevin, and Generali Joyce A, eds. The guide to off-label prescription drugs: New uses for FDA-approved prescription drugs. New York: Free Press, 2006.

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4

Meridia: The weight-loss breakthrough : everything you need to know about the FDA-approved weight-loss pill. Rocklin, CA: Prima Health, 1998.

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5

United States. Dept. of Defense. Office of the Secretary of Defense. and National Defense Research Institute (U.S.), eds. Military use of drugs not yet approved by the FDA for CW/BW defense: Lessons from the Gulf War. Santa Monica, CA: RAND, 1999.

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6

Courtney, Charles H. Veterinary antiparasitic drugs 1991: A comprehensive compendium of FDA-approved antiparasitic drugs. Gainesville, Fla: Institute of Food and Agricultural Sciences, University of Florida, 1991.

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7

United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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8

United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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9

United States. Food and Drug Administration. Office of Public Affairs, ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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10

United States. Food and Drug Administration. Office of Public Affairs., ed. FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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11

Reform, United States Congress House Committee on Government. Risk and responsibility: The roles of FDA and pharmaceutical companies in ensuring the safety of approved drugs, like Vioxx : hearing before the Committee on Government Reform, House of Representatives, One Hundred Ninth Congress, first session, May 5, 2005. Washington: U.S. G.P.O., 2005.

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12

The FDA & Psychiatric Drugs: How a Drug Is Approved. Mason Crest, an Imprint of National Highlights Inc, 2013.

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13

Esherick, Joan. FDA and Psychiatric Drugs: How a Drug Is Approved. Mason Crest, 2014.

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14

List of FDA approved animal drug products. Blacksburg, Va: Laboratory of Veterinary Medical Informatics, VA-MD Regional College of Veterinary Medicine, Virginia Polytechnic Institute and State University, 1987.

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15

FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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16

Loughlin, Kevin, and Joyce Generali. Prescription Drugs: Alternative Uses, Alternative Cures: Over 1,500 New Uses for FDA-Approved Drugs. Pocket, 2007.

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17

The Fda and Psychiatric Drugs: How a Drug Is Approved (Psychiatric Disorders: Drugs & Psychology for the Mind and Body). Mason Crest Publishers, 2003.

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18

Loughlin, Kevin, and Joyce Generali. The Guide to Off-Label Prescription Drugs: New Uses for FDA-Approved Prescription Drugs. Free Press, 2006.

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19

Agarwal, Deepti, Ifeyinwa C. Ifeanyi, and Mercy A. Udoji. Intrathecal Drug Delivery Systems. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190271787.003.0030.

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Intrathecal drug delivery (ITDD), while initially intended for terminal oncology patients suffering from cancer pain, is currently widely used for chronic nonmalignant pain states. Before intrathecal drug delivery device (IDDD) implantation, patients with nonmalignant chronic pain must be screened for psychologic, behavioral, and medical etiologies for their pain, in addition to having a documented failure of maximal medical therapy and a successful intrathecal drug trial. Classes of drugs used for intrathecal therapy include opioids, local anesthetics, adrenergic agonists, and NMDA receptor agonists. Drugs currently approved by the FDA for ITDD are morphine, ziconotide, and baclofen. Complications of IDDD implantation are surgical (bleeding, infection, CSF leak, nerve injury), mechanical (due to catheter kink, shear, or disconnection), pharmacologic (overdose, incorrect pump settings, contaminated drugs), or medical (hypogonadotropic hypogonadism).

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20

Grider, Jay S., Michael E. Harned, and Vital Nagar. Advances in Intrathecal Drug Delivery. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190626761.003.0018.

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Intrathecal drug delivery has become a commonplace means to treat recalcitrant chronic pain of malignant and nonmalignant origins. Although intrathecal drug delivery systems (IDDS) and intrathecal drug delivery (IDD) itself rapidly established themselves in the treatment of malignant pain at the end of life, these therapies are also utilized for treatment of pain of nonmalignant origin. While the only US Food and Drug Administration (FDA)-approved medications for use in the intrathecal space are morphine, baclofen, and ziconotide, this chapter will also address commonly used medications such as clonidine and local anesthetics such as bupivacaine as well. While this chapter serves as general overview of the topic’s long history and rapidly developing literature, a basic understanding of the modality and medications used is important.

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21

Seiden, Othniel J., and Othniel J. Md Seiden. Meridia: The Weight-Loss Breakthrough : Everything You Need to Know About the FDA-Approved Weight-Loss Pill. Prima Lifestyles, 1998.

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22

Foreyt, John P. The Xenical Advantage: How To Use the Remarkable New FDA-Approved Drug to Lose Weight Faster - and Keep It Off -- Safely and Effectively. Simon & Schuster, 1999.

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23

Drerup, Justin M., Curtis A. Clark, and Tyler J. Curiel. Clinical Trials of Ovarian Cancer Immunotherapy and Future Directions. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190248208.003.0013.

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Ovarian cancer (OC) is an immunogenic tumor and among the first where measures of anti-tumor immunity correlated with improved survival. Thus, immunotherapy could be a viable OC treatment modality. Nonetheless, clinical OC immunotherapy trials have demonstrated only modest successes at best, and there is currently no Food and Drug Administration (FDA)approved OC immune therapy despite recent successes in other carcinomas and lymphomas and FDA-approved immunotherapy agents for them. New data suggest specific impediments to effective de novo and treatment-induced anti-OC immunity and support the concept that effective, tolerable OC immunotherapy could be developed based on these newer insights. This chapter reviews the history of OC immunotherapy, highlights important discoveries in OC-related immune dysfunction, covers promising recent developments, highlights newer and ongoing clinical trials, and speculates on future directions that could lead to improved OC immunotherapy approaches.

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24

Sharfstein, Joshua M. Thalidomide. Oxford University Press, 2018. http://dx.doi.org/10.1093/oso/9780190697211.003.0003.

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In 1962, the United States found itself transfixed by a crisis involving the medication thalidomide. Marketed widely in Europe for a variety of ailments, including nausea during pregnancy, thalidomide turned out to be a severe teratogen, causing thousands of severe birth defects in Germany alone. Yet as a result of diligence by the U.S. Food and Drug Administration (FDA), thalidomide was never approved for marketing in the United States.). When the close call came to light, Congress responded by granting the agency new authority, including the unprecedented power to require medications to be proven effective before sale. A key to turning tragedy into progress was the decision to highlight the central role of the FDA reviewer Dr. Frances Oldham Kelsey in protecting the nation.

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25

Kahn, S. Lowell, and Sergio Rojas. Deployment Finesse of the Gore Excluder Stent Graft. Edited by S. Lowell Kahn, Bulent Arslan, and Abdulrahman Masrani. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780199986071.003.0002.

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The Gore Excluder stent graft was approved for use in the United States by the US Food and Drug Administration (FDA) in 2002. The Excluder is a modular, bifurcated endoprosthesis utilized in the treatment of abdominal aortic aneurysms. The Excluder endoprosthesis is constructed from an expanded polytetrafluoroethylene film and an incorporated “weldless” nickel–titanium stent skeleton for support. The device features no sutures, infrarenal fixation, and is made to be inserted through 12–18 Fr introducer sheaths. Since its approval by the FDA, the Excluder has undergone multiple changes, including profile reductions, the addition of an impermeable membrane (due to early graft material design associated with type IV endoleaks), and, most notably, a repositioning mechanism labeled the C3 Excluder. This chapter discusses multiple techniques of deployment of the Gore Excluder stent graft.

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26

Koen, N., T. Amos, J. Ipser, and D. Stein. Antidepressants in Post-Traumatic Stress Disorder. Edited by Charles B. Nemeroff and Charles R. Marmar. Oxford University Press, 2018. http://dx.doi.org/10.1093/med/9780190259440.003.0034.

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This chapter discusses the use of antidepressants in treating symptoms of posttraumatic stress disorder (PTSD). Tricyclic antidepressants were the first psychotropic agents to be studied systematically and rigorously for the treatment of PTSD. While early studies focused both on the tricyclics and monoamine oxidase inhibitors (MAOIs), more recent work has centered on the selective serotonin reuptake inhibitors (SSRIs); and paroxetine and sertraline are currently approved by the U.S. Food and Drug Administration (FDA) for use in this disorder. However, given the relatively small effect sizes in SSRI trials of PTSD, there is a need for ongoing psychopharmacological research to understand underlying mechanisms of antidepressant efficacy and to optimize response to pharmacotherapy. Further data on pediatric PTSD and on medication prophylaxis are needed before routine antidepressant treatment can be endorsed in these contexts.

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27

FDA-approved bargain drugs: Generic products must meet high standards. 2nd ed. Rockville, MD: Dept. of Health and Human Services, Food and Drug Administration, Office of Public Affairs, 2003.

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28

Li, Dr Y. Robert. Cardiovascular Medicine: New Therapeutic Drugs Approved by the US FDA. AIMSCI Inc., 2018.

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29

Cheng, Jerry, and David Madigan. Bayesian approaches to aspects of the Vioxx trials: Non-ignorable dropout and sequential meta-analysis. Edited by Anthony O'Hagan and Mike West. Oxford University Press, 2018. http://dx.doi.org/10.1093/oxfordhb/9780198703174.013.3.

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This article discusses Bayesian approaches to aspects of the Vioxx trials study, with a focus on non-ignorable dropout and sequential meta-analysis. It first provides a background on Vioxx, a COX-2 selective, non-steroidal anti-inflammatory drug (NSAID) approved by the FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, the management of acute pain in adults, and for the treatment of menstrual symptoms. However, Vioxx was found to cause an array of cardiovascular side-effects such as myocardial infarction, stroke, and unstable angina. As a result, Vioxx was withdrawn from the market. The article describes an approach to sequential meta-analysis in the context of Vioxx before considering dropouts in the key APPROVe study. It also presents a Bayesian approach to handling dropout and showcases the utility of Bayesian analysis in addressing multiple, challenging statistical issues and questions arising from clinical trials.

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30

Moeller, Gerard, and Mishka Terplan, eds. Substance Use Disorders. Oxford University Press, 2020. http://dx.doi.org/10.1093/med/9780190920197.001.0001.

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Over the past few years there has been an increased interest in the identification and treatment of substance use disorders, due at least in part to the widespread drug overdose epidemic. Clinicians and the lay public have gained a greater understanding of the need for treatment of substance use disorders and the consequences of avoiding treatment. In addition, there has been a growing understanding of substance use disorders as medical or mental health disorders, rather than as character flaws or merely illegal activities. This book builds on this nascent understanding and presents epidemiology, basic science, and treatment from the perspective of a clinician who wants to gain the knowledge and background needed to work with this patient population. The overall theme of the book is to discuss evidence-based rather than anecdotal or unproved treatments. Section I begins with the epidemiology, etiology, and neurobiology of substance use disorders, including preclinical data. Section II discusses pharmacotherapy for substance use disorders, focusing on medications approved by the US Food and Drug Administration (FDA). Section III focuses on other evidence-based treatments for substance use disorders, including behavioral therapies, and ends with potential future treatments.

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31

Rettig, Richard. Waiving Informed Consent: Military Use of Non-FDA-Approved Drugs in Combat. RAND Corporation, 2000. http://dx.doi.org/10.7249/rb7534.

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32

Drugs under patent: A comprehensive guide to FDA-approved pharmaceuticals under patent and marketing exclusivity. Rockville, MD: FOI Services, 1991.

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33

Rettig, Richard. Military Use of Drugs Not Yet Approved by the FDA for CW/BW Defense: Lessons from the Gulf War. RAND Corporation, 1999. http://dx.doi.org/10.7249/mr1018.9.

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34

Congress, United St, Committee on Government Reform Staff, and United States House of Representatives. Risk and Responsibility: The Roles of FDA and Pharmaceutical Companies in Ensuring the Safety of Approved Drugs, Like Vioxx. Independently Published, 2020.

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35

Ng, Bernardo, and Mauricio Tohen. Evidence-based treatment of mania. Oxford University Press, 2017. http://dx.doi.org/10.1093/med/9780198748625.003.0004.

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Bipolar mania can be one of the most challenging psychiatric illnesses to treat, as it requires the clinician to make rapid and accurate decisions; have a reliable way of evaluating progress and treatment response; and possess keen psychotherapeutic skills. Therefore, the importance of staying updated on the clinical evidence of the various treatment options, which serves as the basis to individualize treatment on the day-to-day progress or deterioration of the manic patient. This chapter presents a review available on the evidence of different psychopharmacological agents including typical antipsychotics, lithium, antiepileptic drugs and atypical antipsychotics, and FDA-approved dosages. This review also includes these agents’ effects on fertility and recommendations about their use during pregnancy and lactation. Bipolar disorder continues to be a complex psychiatric condition, yet the progress in treatment options for the manic phase has evolved such that we have more options than ever before.

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36

Risk and Responsibility: The Roles of FDA and Pharmaceutical Companies in Ensuring the Safety of Approved Drugs, Like Vioxx: Hearing Before the. Not Avail, 2005.

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Books on the topic 'FDA-approved drug'

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