• New Batch of Counterfeit Cancer Drug Avastin Found in US

    The US Food and Drug Administration (FDA) warned the public 3 April of newly-found counterfeit bevacizumab (Avastin) containing no active ingredient-the second case to occur within the last two months. FDA previously warned consumers and healthcare professionals about counterfeit batches of Avastin on 14 February 2012 , when it found an unauthorized supplier selling the counterfeit drug. As many as 19 medical practices had purchased the counterfeit drug. FDA's newest s...
  • Generic Boniva Approved, Marking Next Big Patent Expiry

    The US Food and Drug Administration (FDA) approved the first generics version of Roche Holding AG's blockbuster osteoporosis drug Boniva (ibandronate), marking the next big patent expiry for the pharmaceutical industry this year. The generic ibandronate will be manufactured by Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals, and will be accompanied by an FDA-required Medication Guide (MedGuide) warning patients about the risks associated with the drug. Boniva h...
  • Agency Releases Rationale Behind Withdrawal of Avastin's Breast Cancer Indication

    The US Food and Drug Administration (FDA) released on 27 February the text of their final decision on their withdrawal of Avastin's (bevacizumab) breast cancer indication . FDA Commissioner Margaret Hamburg's 69-page decision is meant to be an explanation of FDA's application of the law and relevant regulations in its decision to withdraw approval for Avastin's breast cancer indication. Avastin is still marketed for several other indications. The action followed a pu...
  • Counterfeit Avastin Found in US, Warns FDA

    Counterfeit copies of Roche Holding AG's anticancer drug Avastin (bevacizumab) have been found in the US, the US Food and Drug Administration (FDA) warned on 14 February. According to investigators at Genentech, a subsidiary of Roche, the counterfeit copies did not contain the active pharmaceutical ingredient (API) that makes the drug safe and effective for its approved indications. Reporting by The Wall Street Journal indicates that supplies of the counterfeit produ...