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News Mylan Confirms First-to-File Patent Challenge Relating to Actoplus Met XR Tablets
Mylan confirmed that the company has been sued by Takeda Pharmaceutical Company, Watson Pharmaceuticals and Andrx Labs in connection with the filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Pioglitazone Hydrochloride and Extended-release Metformin Hydrochloride tablets, 15 mg/1000 mg and 30 mg/1000 mg. |
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News FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines
The U.S. Food and Drug Administration (FDA) is informing the public that the Agency has approved updated drug labels for the pioglitazone-containing medicines to include safety information that the use of pioglitazone for more than one year may be associated with an increased risk of bladder cancer. |
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News FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer
The U.S. Food and Drug Administration (FDA) is informing the public that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. |
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News Update on ongoing European review of pioglitazone–containing medicines
The European Medicines Agency (EMA) has been informed by the French Medicines Agency (Afssaps) of its decision to suspend the use of pioglitazone-containing medicines in France (Actos, Competact), while awaiting the outcome of the ongoing European review on the benefits and risks of these antidiabetic medicines. |
