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Stephanie Sutton was an assistant editor at Pharmaceutical Technology Europe.
Teva Pharmaceuticals in the US has admitted to including false statements in the physician prescribing information for its oral contraceptive product Gianvi, a generic version of Bayer Healthcare?s YAZ oral contraceptive.
Teva Pharmaceuticals in the US has admitted to including false statements in the physician prescribing information for its oral contraceptive product Gianvi, a generic version of Bayer Healthcare’s YAZ oral contraceptive.
The information claimed that the ethinyl estradiol in Gianvi was stabilized by Bayer’s patented “betadex as a clathrate” formulation; however the stabilization formulation has not been used in the product.
Teva has agreed to correct the false label by sending weekly email or fax messages, which will contain the corrected prescribing information and remove the false claim, to US pharmacies nationwide for 3 months. The company will also send emails or faxes to all known wholesalers, distributors and chain retailers that received Gianvi to notify them of the changes, and has agreed not to ship any additional Gianvi product containing promotional materials, packaging inserts or any other material that makes the false claim.
Bayer, who initiated the lawsuit, had requested a motion for a temporary restraining order, but this was denied following Teva’s agreement to take corrective measures. Despite this, a press statement described Bayer as “pleased” with the Court’s decision.
However, there may still be further trouble ahead for Teva and Gianvi. Teva launched the generic product in June 2010, despite a previous agreement with Bayer that prevents Teva from launching the generic before July 2011. According to many third-party sources, including Reuters, Bloomberg and AboutLawsuits.com, Bayer will sue Teva for patent infringements.
The company has good reason to defend YAZ. According to IMS sales data, total sales of YAZ tablets exceeded $700 million in the US in 2009.