Teva changes generic Yaz contraceptive label

Generics and biosimilars Initiative

Building trust in cost-effective treatments

Inscribirse
eng / esp

Teva changes generic Yaz contraceptive label

Genéricos/Novedades | Posted 09/07/2010 0 Post your comment

Israeli generic giant Teva Pharmaceuticals has agreed to change the labelling on its generic oral contraceptive, Gianvi, after Bayer Schering Pharma (Bayer) filed a lawsuit accusing the company of falsely claiming its drug was identical to Bayer’s Yaz.

The suit alleged that Teva’s launch materials and package insert falsely claimed that Gianvi, a generic version of Yaz (drospirenone/ethinyl estradiol), contains ethinylestradiol stabilised by β-cyclodextrin (‘betadex’) as a ‘clathrate’ (a protective molecular cage). Based on testing of tablets now in the US market, Bayer believed that Gianvi did not use betadex as a stabiliser.

Teva admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi, falsely claimed that the ethinyl estradiol in the product was stabilised by Bayer’s patented ‘betadex as a clathrate’ formulation, and in fact, that Gianvi does not have Bayer’s patented stabilisation formulation.

Teva reported that it has already provided the US FDA with corrected Physician Prescribing Information for Gianvi and that it has corrected the Gianvi label information on the Teva US website.

The German drugmaker thought it had both its Yasmin and Yaz birth control products protected in the US until next year.

It is estimated that Bayer could lose Euros 200 million in sales of the drug in year 2010 and Euros 250 million in year 2011. The publicity around these false claims could, however, put a damper on sales of the generic, with women demanding the stabilised contraceptive.

Reference:

Bayer News Release, Teva Admits to Making False Statements in US Gianvi™ Label and Agrees to Corrective Measures, 17 June 2010