TITLE

Denosumab Receives Conditional Approval from FDA Expert Panel

PUB. DATE
October 2009
SOURCE
Travel Medicine Advisor;Sep2009 Supplement, p2
SOURCE TYPE
Periodical
DOC. TYPE
Article
ABSTRACT
The article reports on the conditional approval given by the U.S. Food and Drug Administration (FDA) Expert Panel on the new human monoclonal antibody denosumab. It cites that FDA has evaluated the drug for treatment of osteoporosis in men and women. It discusses the results of two industry-sponsored studies concerning the effectiveness of denosumab. Further, it notes that the drug will be marketed by Amgen Inc. under the trade name Proliaâ„¢ once received its full approval from FDA.
ACCESSION #
44834096

 

Related Articles

  • Denosumab Receives Conditional Approval from FDA Expert Panel. Elliott, William T. // Neurology Alert;Oct2009 Pharmacology Watch, p2 

    The article reports that a condition approval has been given to Denosumab, a new human monoclonal antibody, by a Food and Drug Administration (FDA) Expert Panel. The agency is testing the drug for treatment of osteoporosis in men and women. The drug would be branded as Proliaâ„¢ by Amgen...

  • Denosumab Receives Conditional Approval from FDA Expert Panel. Elliott, William T. // Infectious Disease Alert;Oct2009 Supplement, p2 

    The article reports on a conditional approval given by the U.S. Food and Drug Administration (FDA) Expert Panel for denosumab, a human monoclonal antibody, for treatment of osteoporosis in men and women. It provides an overview of industry-sponsored studies which suggest that the drug is...

  • FDA Approvals In June.  // BioWorld Insight;7/15/2013, Vol. 21 Issue 29, p7 

    A table is presented which lists the drugs approved by the U.S. Food and Drug Administration and their company including Xgeva from Amgen Inc., Revlimid from Celgene Corp. and Vibativ from Theravance Inc. and also offers information on their theurapeutic effect.

  • FDA Submissions, Approvals & Other Actions: June 2013.  // BioWorld Insight;7/15/2013, Vol. 21 Issue 29, p39 

    A chart is presented depicting the status of the U.S. Food and Drug Administration's submissions and approvals of various drugs including the Xgeva from Amgen Inc., the Revlimid from Celgene Corp. and the Sefelsa from Depomed Inc., along with information on their description and clinical use.

  • AMGEN. Investor's Business Daily // Investors Business Daily;4/16/2015, pA02 

    The article reports on the approval of the U.S. Food and Drug Administration (FDA) for Corlanor drug manufactured by biopharmaceutical company Amgen Inc. on top of standard beta blockers for chronic heart failure patients.

  • Amgen drug misses fast track. Investor's Business Daily // Investors Business Daily;4/28/2015, pA02 

    The article reports on the statement of a staff of the U.S. Food and Drug Administration (FDA) claiming that the skin cancer drug talimogene laherparepvec (T-Vec) of biopharmaceutical company Amgen Inc. is not eligible for accelerated review for the moment.

  • FDA approves first bispecific. Mullard, Asher // Nature Reviews Drug Discovery;Jan2015, Vol. 14 Issue 1, p7 

    The article reports that Amgen Inc.'s blinatumomab, a CD19- and CD3-targeting bispecific antibody for acute B-cell lymphoblastic leukaemia, had been approved by the U.S. Food and Drug Administration (FDA) 5 months ahead of schedule.

  • Boniva.  // Formulary;May2005, Vol. 40 Issue 5, p144 

    Reports on U.S. Food and Drug Administration's approval of Boniva ibandronate 150-mg tablets, a first once-monthly therapy from Roche and Glaxosmithkline for treatment and prevention of osteoporosis. Efficacy and safety; Dosing.

  • New drugs: Denosumab, dienogest/estradiol valerate, and polidocanol. Hussar, Daniel A.; Stevenson, Takyiah // Journal of the American Pharmacists Association: JAPhA;Sep/Oct2010, Vol. 50 Issue 5, p658 

    The article discusses new drugs and medications that have been approved for marketing by the U.S. Food and Drug Administration, including adverse risks involved. Denosumab, a treatment for osteoporosis, may exacerbate hypocalcemia. Dienogest that is used with estradiol valerate as an oral...

Share

Read the Article

Courtesy of VIRGINIA BEACH PUBLIC LIBRARY AND SYSTEM

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics