Teva admits making false claims about contraceptive
WAYNE, N.J. Teva Pharmaceutical Industries admitted before a federal court Thursday to making false statements about the generic oral contraceptive Gianvi (drospirenone and ethinyl estradiol), a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.
Bayer had sued Teva in the U.S. District Court for the Northern District of Illinois for false advertising and patent infringement, accusing the world’s largest generic drug maker of falsely claiming in Gianvi’s prescribing information that the ethinyl estradiol uses the chemical beta-cyclodextrin as a “clathrate” to stablize it and prolong its shelf life, a patented Bayer technology. In its lawsuit, Bayer said an analysis of Gianvi found it did not use beta-cyclodextrin as a clathrate.
Teva said it would rectify the situation by sending weekly e-mails and faxes to pharmacists throughout the United States for three months that contain corrected prescribing information and had already provided the corrected information to the Food and Drug Administration. It also agreed not to ship any more Gianvi products containing any material claiming that the drug uses beta-cyclodextrin as a clathrate.
Teva received FDA approval for its version of the drug on June 1. Yaz had $782 million in sales in 2009, according to IMS Health.
FDA approves Jevtana
SILVER SPRING, Md. The Food and Drug Administration has approved a new treatment for advanced prostate cancer, the agency said Thursday.
The FDA announced the approval of Sanofi-Aventis’ Jevtana (cabazitaxel), a chemotherapy drug used with the steroid prednisone. The agency said the drug was the first treatment for advanced, hormone-refractory prostate cancer that has worsened during or after treatment with docetaxel, also a chemotherapy drug used in advanced prostate cancer. Hormone refractory prostate cancer happens when prostate tumors continue to grow despite treatments meant to reduce the body’s production of the male hormone testosterone, which helps prostate tumors grow.
“Patients have few therapeutic options in this disease setting,” FDA Center for Drug Evaluation and Research Office of Oncology Products director Richard Pazdur said. “FDA was able to review and approve the application for Jevtana in 11 weeks, expediting the availability of this drug to men with prostate cancer.”
Report: Oregon State Board of Pharmacy declares marijuana as drug with medical use
SALEM, Ore. The makers of the 1930s documentary “Reefer Madness” would be furious at the news, but it likely will come as a relief to people with certain diseases and marijuana law-reform advocates.
The Oregon State Board of Pharmacy voted Wednesday to have marijuana classified as a drug with medical use, according to reports from a local TV station. The decision makes the state to reclassify it as such.
Under the decision, marijuana will be known as a Schedule II controlled substance, meaning that it has high potential for abuse but still has medical benefits. Previously — and still in all other states — marijuana was a Schedule I drug, meaning it had no medical benefits.