Sexual and Reproductive Health

Pharma company received action letter from U.S. FDA for contraceptive implant

Published in Medical Letter on the CDC and FDA, July 24th, 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 new drug application (NDA).

The company is currently reviewing the U.S. Food and Drug Administration's (FDA) 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, Jersey, USA and Oss, The Netherlands, creates manufactures and...

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Source: Medical Letter on the CDC and FDA (2005-07-24)

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