• 26 February 2014

    Collaboration in pharmacovigilance strengthen by FDA and EMA

    A new "cluster" have set up on medicinal safety topics by join efforts of U.S. Food and Drug Administration and the European Medicines Agency (EMA). Clusters are regular collaborative meetings between the EMA and regulators outside of the European Union, which focus on specific topic areas that have been identified as requiring an intensified exchange of information and collaboration.

  • 19 February 2014
    New Drug Approval for treatment of neurogenic orthostatic hypotension

    The USFDA approved Chelsea Therapeutics's product Northera capsules (droxidopa), orphan-product, for the treatment of neurogenic orthostatic hypotension (NOH) which is rare, chronic and often debilitating drop in blood pressure upon standing that is associated with Parkinson's disease, multiple-system atrophy,

  • 7 July 2011
    USFDA bans import of products from Dr Reddy's Mexico plant

    The US health regulator has imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices (CGMP).

  • 7 July 2011
    Zydus Cadila sent warning letter after FDA finds microbiology problems

    The FDA has sent a warning letter to Cadila Healthcare’s Ahmedabad, India finished products plant after an inspection found GMP deviations.

  • 12 February 2011
    Anesthesiologists Ask FDA to Okay Importation of Sodium Thiopental

    The American Society of Anesthesiologists (ASA) has asked the US Food and Drug Administration (FDA), for the sake of patient safety, to work with foreign governments to allow for the importation of sodium thiopental (Pentothal, Hospira) because domestic production of the controversial agent ceased in 2009.

  • 30 August 2010
    Inform All: FDA Warns Consumers to Avoid TimeOut Capsules

    The U.S. Food and Drug Administration is warning consumers not to take TimeOut Capsules because it contains an active drug ingredient that can dangerously lower blood pressure. The product is marketed as a dietary supplement for sexual enhancement.

  • 27 April 2010
    Glenmark's oral contraceptive gets FDA nod

    Glenmark's US subsidiary Glenmark Generics has been granted approval by the United States Food and Drug Administration (FDA) for Norethindrone tablets 0.35mg—its generic version of Nor-QD. The product will be marketed under the trade name Heather and distribution is expected to start immediately.

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