Home

news003

GSK Receives EMEA Approval for Duodart

LONDON (AP) - Pharmaceutical company GlaxoSmithKline PLC has received European approval for Duodart, a two-in-one drug for the treatment of the symptoms of an enlarged prostate.

The drug is a combination of dutasteride, currently marketed as Avodart, and tamsulosin, a generic drug marketed by Astellas Pharma as Flomax.

Glaxo received backing for the drug from Germany under the European Union's decentralized approval procedure, meaning it is applicable across the 27-member bloc. The company said national licenses are expected to be granted throughout the year.

Prostate enlargement is an increasingly common condition for men as they age. Almost four in 10 men over the age of 65 have the condition, which occurs when there is an overgrowth of cells in the prostate gland, blocking the flow of urine.

Duodart is a once-daily dose to treat the condition.

In December, Glaxo withdrew its application to U.S. regulators to use Avodart to prevent prostate cancer, saying it wanted to provide an update after its initial research showed the drug could reduce the risk of that cancer by about 25 percent.

Shares in Glaxo, the world's No. 2 drug maker, were 0.3 percent lower at 1,260 pence in morning trade on the London Stock Exchange.

Source: Associated Press

News & Events

  • Food and Drug Administration NOTICES Meetings:   Internationa... Read more>>
  • T Cell Proliferation Assays ProImmune Ltd, a leader in epitope discovery, immunogenicity, an... Read more>>
  • Novozymes Partnering With ProMetic Life Sciences Inc.Drug Discovery & Development - April 0... Read more>>
  • FDA Says Additional Pixuvri Trial Needed, CTI Opens Drug to Expanded Access Cell Therapeutics... Read more>>
  • in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and... Read more>>
  • AllTranz Developing Multi-Use Transdermal Patch   AllTranz, Lexington, Ky., is focused on t... Read more>>
  • Statins May Slow Progression Of Multiple Sclerosis, New Study Finds A UCSF-led study exa... Read more>>
  • Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>
  • GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
  • U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil h... Read more>>
  • FDA Approves Mylan’s Drug Applications Mylan Inc. Monday announced that its subsidiary Mylan Ph... Read more>>
  • FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>