Teva admits to making false statements in US copy version of Bayer's YAZ, Gianvi, label and agrees to corrective measures

In proceeding before Judge Virginia Kendall in US Federal Court in the Northern District of Illinois this week, the US subsidiary of Israeli generics giant Teva Pharmaceuticals Industries admitted that the Physician Prescribing Information included with packages of its oral contraceptive Gianvi falsely claimed that the ethinyl estradiol in the contraceptive product was stabilized by Bayer's patented "betadex as a clathrate" formulation.

Gianvi is Teva's copy version of German drug major Bayer HealthCare's leading oral contraceptive YAZ (drospirenone and ethinyl estradiol), but does not have Bayer's patented stabilization formulation, the latter firm stated.

In response to Bayer's motion for a temporary restraining order and at the end of the hearing before Judge Kendall on the motion, Teva agreed to correct the false label by sending weekly e-mail or fax messages to US pharmacists nationwide for a period of three months. The e-mail or fax messages to pharmacists will provide corrected Physician Prescribing Information that removes the false claim that the ethinyl estradiol in Gianvi is stabilized by betadex as a clathrate and calls the pharmacist's attention to this corrective label change.