Repositioning Food and Drug Administration-Approved Drugs for Inhibiting Biliverdin IXβ Reductase B as a Novel Thrombocytopenia Therapeutic Target

2021 ◽  
Author(s):  
Myeongkyu Kim ◽  
Jung-Hye Ha ◽  
Joonhyeok Choi ◽  
Bo-Ram Kim ◽  
Vytautas Gapsys ◽  
...  
Keyword(s):  
Drug Administration ◽  
Therapeutic Target ◽  
Food And Drug Administration ◽  
Approved Drugs

scholarly journals Small-Molecule Screens: A Gateway to Cancer Therapeutic Agents with Case Studies of Food and Drug Administration–Approved Drugs

2017 ◽  
Vol 69 (4) ◽  
pp. 479-496 ◽  
Author(s):  
Nathan P. Coussens ◽  
John C. Braisted ◽  
Tyler Peryea ◽  
G. Sitta Sittampalam ◽  
Anton Simeonov ◽  
...  
Keyword(s):  
Case Studies ◽  
Drug Administration ◽  
Small Molecule ◽  
Food And Drug Administration ◽  
Therapeutic Agents ◽  
Approved Drugs

Unapproved Uses of Approved Drugs: The Physician, the Package Insert, and the Food and Drug Administration: Subject Review

PEDIATRICS ◽  
1996 ◽  
Vol 98 (1) ◽  
pp. 143-145 ◽  
Author(s):  
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Age Groups ◽  
Package Insert ◽  
Age Group ◽  
Off Label Use ◽  
Off Label ◽  
Fda Approval ◽  
Approved Drugs

Physicians who prescribe a new drug that has not been approved for a specific indication or a specific age group frequently find themselves in a quandary. Physicians who prescribe "old," time-honored drugs usually do not consult the package insert or search for US Food and Drug Administration (FDA) approval. This statement was written to clarify the legal and informational status of the package insert and the role of the FDA in approving or not approving drugs for specific indications or specific age groups. The unapproved use of approved drugs, or so-called "off-label" use, is extremely prevalent among physicians who care for children. It is important that such use of compounds be brought up to date with current FDA policies and to emphasize the responsibility of the prescribing physician in the use of these compounds.

Report of the Council on Scientific Affairs: Unlabeled Indications of Food and Drug Administration-Approved Drugs

1998 ◽  
Vol 32 (4) ◽  
pp. 1049-1061 ◽  
Author(s):  
Joseph W. Cranston ◽  
Michael A. Williams ◽  
Nancy H. Nielsen ◽  
Rebecca J. Bezman
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Approved Drugs

scholarly journals Screening and Identification of Lujo Virus Entry Inhibitors From an Food and Drug Administration-Approved Drugs Library

2021 ◽  
Vol 12 ◽  
Author(s):  
Junyuan Cao ◽  
Siqi Dong ◽  
Yang Liu ◽  
Minmin Zhou ◽  
Jiao Guo ◽  
...  
Keyword(s):  
Drug Administration ◽  
High Throughput Screening ◽  
Food And Drug Administration ◽  
Critical Role ◽  
Lymphocytic Choriomeningitis ◽  
Channel Blockers ◽  
Entry Inhibitors ◽  
Tm Domain ◽  
Virus Entry Inhibitors ◽  
Approved Drugs

Lujo virus (LUJV) belongs to the Old World (OW) genus Mammarenavirus (family Arenaviridae). It is categorized as a biosafety level (BSL) 4 agent. Currently, there are no U.S. Food and Drug Administration (FDA)-approved drugs or vaccines specifically for LUJV or other pathogenic OW mammarenaviruses. Here, a high-throughput screening of an FDA-approved drug library was conducted using pseudotype viruses bearing LUJV envelope glycoprotein (GPC) to identify inhibitors of LUJV entry. Three hit compounds, trametinib, manidipine, and lercanidipine, were identified as LUJV entry inhibitors in the micromolar range. Mechanistic studies revealed that trametinib inhibited LUJV GPC-mediated membrane fusion by targeting C410 [located in the transmembrane (TM) domain], while manidipine and lercanidipine inhibited LUJV entry by acting as calcium channel blockers. Meanwhile, all three hits extended their antiviral spectra to the entry of other pathogenic mammarenaviruses. Furthermore, all three could inhibit the authentic prototype mammarenavirus, lymphocytic choriomeningitis virus (LCMV), and could prevent infection at the micromolar level. This study shows that trametinib, manidipine, and lercanidipine are candidates for LUJV therapy and highlights the critical role of calcium in LUJV infection. The presented findings reinforce the notion that the key residue(s) located in the TM domain of GPC provide an entry-targeted platform for designing mammarenavirus inhibitors.

scholarly journals FDA Experience with Medical Countermeasures under the Animal Rule

2012 ◽  
Vol 2012 ◽  
pp. 1-11 ◽  
Author(s):  
Paul Aebersold
Keyword(s):  
Drug Administration ◽  
Food And Drug Administration ◽  
Biological Products ◽  
The Public ◽  
Investigational Drugs ◽  
Final Rule ◽  
Life Threatening ◽  
Approved Drugs ◽  
Animal Rule ◽  
Medical Countermeasures

The Food and Drug Administration issued a final rule in May 2002 to permit the Agency to approve drugs or license biological products on the basis of animal efficacy studies for use in ameliorating or preventing serious or life-threatening conditions caused by exposure to lethal or permanently disabling toxic biological, chemical, radiological, or nuclear substances. Only two drugs were approved in the first nine years of the “Animal Rule” despite massive investment by the federal government since 2001 to stimulate development of medical countermeasures to biological threats. This article therefore examines the Food and Drug Administration reviews made public after approval of those two drugs and the public discussion at the Agency's Anti-Infective Drugs Advisory Committee of one biological product under development under the Animal Rule. Despite the paucity of approved drugs or licensed biological products as medical countermeasures, several investigational drugs have been placed in the National Strategic Stockpile for use as medical countermeasures, if needed.

Repurposing Food and Drug Administration–Approved Drugs to Promote Antitumor Immunity

2019 ◽  
Vol 25 (2) ◽  
pp. 88-99 ◽  
Author(s):  
Vidula V. Sukhatme ◽  
Suresh S. Ramalingam ◽  
Rafi Ahmed ◽  
Vikas P. Sukhatme
Keyword(s):  
Drug Administration ◽  
Antitumor Immunity ◽  
Food And Drug Administration ◽  
Approved Drugs

scholarly journals A year in pharmacology: new drugs approved by the US Food and Drug Administration in 2020

2021 ◽  
Author(s):  
Gizem Kayki-Mutlu ◽  
Martin C. Michel
Keyword(s):  
Small Molecules ◽  
Drug Administration ◽  
Antisense Oligonucleotides ◽  
Food And Drug Administration ◽  
New Drugs ◽  
Small Interfering Rnas ◽  
Drug Discovery And Development ◽  
The Past ◽  
The Us ◽  
Approved Drugs

AbstractWhile the COVID-19 pandemic also affected the work of regulatory authorities, the US Food and Drug Administration approved a total of 53 new drugs in 2020, one of the highest numbers in the past decades. Most newly approved drugs related to oncology (34%) and neurology (15%). We discuss these new drugs by level of innovation they provide, i.e., first to treat a condition, first using a novel mechanisms of action, and “others.” Six drugs were first in indication, 15 first using a novel mechanism of action, and 32 other. This includes many drugs for the treatment of orphan indications and some for the treatment of tropical diseases previously neglected for commercial reasons. Small molecules continue to dominate new drug approvals, followed by antibodies. Of note, newly approved drugs also included small-interfering RNAs and antisense oligonucleotides. These data show that the trend for declines in drug discovery and development has clearly been broken.

scholarly journals Recent New Drug Approvals, Part 2: Drugs Undergoing Active Clinical Studies in Children

2013 ◽  
Vol 18 (1) ◽  
pp. 14-38 ◽  
Author(s):  
Rebecca F. Chhim ◽  
Chasity M. Shelton ◽  
Michael L. Christensen
Keyword(s):  
Drug Administration ◽  
Clinical Studies ◽  
Food And Drug Administration ◽  
New Drug ◽  
The Us ◽  
Drug Approvals ◽  
Approved Drugs

The objective of this 2-part review is to provide information about drugs that have been recently approved by the US Food and Drug Administration. Part 1 reviewed recently approved drugs with pediatric indications. Part 2 reviews drugs recently approved only in adults and have published or ongoing studies in children.

Sign in / Sign up

Export Citation Format

Share Document