Implanon

etonogestrel

Organon Receives Approvable From FDA for Contraceptive Implant

ROSELAND, N.J., June 21, 2005 -- Organon received an Action letter from the U.S. Food and Drug Administration (FDA) for its implantable contraceptive, Implanon (etonogestrel implant) which maintained the "approvable" status of this NDA. We are currently reviewing the FDA's response and will meet with the agency over the next few weeks to address the outstanding issues.

Organon is confident that it will be able to provide the FDA with the appropriate information to expedite their review.

Organon -- with shared head offices in Roseland, NJ, USA and Oss, The Netherlands creates, manufactures and markets prescription medicines that improve the health and quality of human life. Through a combination of independent growth and business partnerships, Organon strives to remain or become one of the leading pharmaceutical companies in each of its core therapeutic fields: reproductive medicine, psychiatry and anesthesia. Organon products are sold in over 100 countries, of which more than 60 have an Organon subsidiary. Organon is the human health care business unit of Akzo Nobel.

Akzo Nobel NV, based in the Netherlands, serves customers throughout the world with healthcare products, coatings and chemicals. Consolidated revenues for 2004 totaled EUR 12.9 billion. The company currently employs some 61,000 people in more than 80 countries. The financial results for the second quarter will be published on July 20, 2005.

Related Articles:

Implanon Organon - Treatment for Contraception - July 18, 2006

Akzo Nobel’s Contraceptive Implanon Receives “approvable” Status from the FDA - November 3, 2004

Latest New Drug Applications...

Daily MedNews
Pharma Industry News
New Drug Applications
New Drug Approvals
Clinical Trial Results
Generic Drug Approvals