Healthy Skepticism Library item: 18204

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Teva admits Gianvi label information was false: Bayer
Reuters 2010 Jun 17
http://www.reuters.com/article/idUSSGE65G0IF20100617

Abstract:

• Teva to correct label information: Bayer
• Teva has provided FDA with corrected info

Full text:

Bayer said Teva’s U.S. unit admitted in a court proceeding on Wednesday that some of the information included on packages of its oral contraceptive Gianvi was false and agreed to correct its labeling.

Bayer said Gianvi, a generic version of Bayer’s YAZ birth control pill sold in the United States, falsely claimed that it contained Bayer’s technology that extended the shelf life of the drug.

Teva will inform U.S. pharmacists on a weekly basis for three months about the corrected physician prescribing information on the label, Bayer said in a statement.

Teva has already provided the U.S. Food and Drug Administration with the corrected information and has also corrected the labeling of the drug on its U.S. website, Bayer said.

Teva could not be immediately reached for a comment.