TITLE

FDA ACCEPTS XYREM SNDA FOR REVIEW

PUB. DATE
May 2005
SOURCE
Biotech Business;May2005, Vol. 18 Issue 5, p2
SOURCE TYPE
Trade Publication
DOC. TYPE
Article
ABSTRACT
Reports on the decision of the U.S. Food and Drug Administration to accept for filing the Supplemental New Drug Application (sNDA) of Orphan Medical Inc. for its Xyrem(R) (sodium oxybate) oral solution. Marketing strategy for Xyrem; Target diseases for treatment using Xyrem; Fee received by Orphan Medical from UCB Pharma for the submission of the sNDA.
ACCESSION #
16900618

 

Related Articles

  • Pipeline.  // Medical Marketing & Media;May2009, Vol. 44 Issue 5, p10 

    The article offers news briefs related to the U.S. Food and Drugs Administration (FDA) and various drug industry in the U.S. The Keppra XR of UCB Pharma Inc. has received a new dosage strength from FDA, which will allow doctors to decrease the number of the patient's dosage. The FDA has...

  • Applications Update.  // PharmaWatch: Biotechnology;Dec2005, Vol. 4 Issue 12, p11 

    The article presents developments related to the pharmaceutical industry. Biothera has filed an investigational new drug application with the U.S Food & Drug Administration (FDA) for its drug Imprime PGG for the treatment of cancer. The FDA plans to complete its review of a marketing submission...

  • UCB GETS POSITIVE RESULTS FROM TWO CIMIZIA PHASE III STUDIES.  // Worldwide Biotech;Feb2007, Vol. 19 Issue 2, p2 

    The article reports that UCB got positive results for signs and symptoms from two Cimzia phase III studies in the treatment of rheumatoid arthritis. UCB has also received a complete response letter from the U.S. Food and Drug Administration requesting additional information and clarification on...

  • NEWSLINE.  // Monthly Prescribing Reference;Jul2010, Vol. 26 Issue 7, pA.20 

    The article offers updates related to the pharmaceutical industry in the U.S. The Food & Drug Administration (FDA) has revised labelling of the long-acting beta agonist (LABA)- containing respiratory medications. Vimpat, lacosamide, an adjunct treatment of partial-onset seizures in patients...

  • Mylan wins FDA approval for generic Keppra.  // PharmaWatch: CNS;Dec2008, Vol. 7 Issue 12, p8 

    The article reports on the approval by the U.S. Food and Drug Administration on Mylan Pharmaceuticals Inc.'s abbreviated new drug application for levetiracetam tablets, 250, 500 and 750 milligram (mg), which is the generic version of UCB Pharma Inc.'s Keppra. It relates that pursuant to the...

  • Decision Update.  // PharmaWatch: Biotechnology;Jun2008, Vol. 7 Issue 6, p11 

    The article presents updates on the status of drugs currently developed by biopharmaceutical companies. The U.S. Food and Drug Administration (FDA) recommends Lev Pharmaceuticals Inc.'s Cinryze for treatment of hereditary angioedema. The European Commission has approved Cephalon Inc.'s Effentora...

  • Biotechnology News Round-up.  // PharmaWatch: Biotechnology;Dec2005, Vol. 4 Issue 12, p2 

    The article presents developments related to the pharmaceutical industry. The trials by Genentech Inc.'s Herceptin reduces the risk of breast cancer recurrence by 52% in women. Belgium-based UCB Pharma Inc. filed a supplemental new drug application with the U.S. Food & Drug Administration...

  • Regulation and Risk Management. Wechsler, Jill // Applied Clinical Trials;Oct2003, Vol. 12 Issue 10, p20 

    Discusses the plans of the U.S. Food and Drug Administration (FDA) to rewrite rules governing electronic records to encourage risk-based regulatory approaches. Announcement of several policies related to the campaigns of the FDA to update good manufacturing practice requirements for human and...

  • Washington update. Wechsler, Jill // Formulary;Dec95, Vol. 30 Issue 12, p840 

    Examines the US Food and Drug Administration's (FDA) draft proposal calling for manufacturer drug efficacy and cost-effectiveness claims to be based on two adequate and well-controlled studies. Effect on manufacturer promotional practices particularly by companies linked to pharmacy benefit...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

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

Try another library?
Sign out of this library

Other Topics