• U.S. FDA approval for Eliquis® (apixaban) to reduce risk of thrmobosis in Hip or Knee Replacement Surgery

    Bristol-Myers Squibb Company and Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) approved a Supplemental New Drug Application (sNDA) for Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery.

  • GSK marketed products Mekinist in combination with Tafinlar received FDA nod for Advanced Melanoma

    FDA approved combination therapy of Mekinist (trametinib) and Tafinlar (dabrafenib) for treatment of advanced melanoma that is unresectable or metastatic. In May 2013, FDA had already approved both drugs as single agents to treat patients with unresectable or metastatic melanoma, skin cancer.

  • Gujarat plant of Sun Pharma hit by import ban from FDA

    Karkhadi (Gujarat) based plant of Sun Pharmaceuticals imposed ban by USFDA. This ban is applied on import of all drug products from this plant. This detention was carried out without physical examination of drugs because company failed to met good manufacturing practices rules, as per FDA website on Wednesday.

  • FDA issued warning letter against Indian based Canton Laboratories upon quality issues

    During  their last investigation in April 2013 at Canton Laboratories- Vadodara,  U.S. food and Drug Administration (FDA) identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) and in view of it, FDA issued a warning letter.

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  • Cefaly gets FDA approval for marketing - First medical device approved to prevent migraine

    U.S. Food and Drug Administration allowed marketing of the first device, Cefaly-manufactured by STX-Med in Belgium, as a preventative treatment for migraine headaches. This is also the first transcutaneous electrical nerve stimulation (TENS) device specifically authorized for use prior to the onset of pain.

  • 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.

  • 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,

  • 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).

  • 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.

  • 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.

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