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.
Pharma News
Glenmark settles litigation with Daiichi Sankyo & Genzyme for colesevelam hydrochloride
Glenmark Pharmaceuticals today announced the settlement of litigation with Daiichi Sankyo and Genzyme Corporation regarding Glenmark's Abbreviated New Drug Application (ANDA) tiled with the US Food and Drug Administration (FDA) for Colesevelam Hydrochloride, a drug used in treatment of type-2 diabetes.
European Union BAN ON AYUSH DRUGS
India has, so far, failed to get any assurance from the European Union to reconsider its ban on Indian herbal medicines even though the issue was raised at the EU through the official channel several times.
The ban has come into effect from May 1, 2011, following a new EU regulatory procedure that was approved seven years back.
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Novartis drug Afinitor extends progression-free survival in patients with advanced pancreatic neuroendocrine tumors
The New England Journal of Medicine (NEJM) published a study that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET)[1].
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.
FDA Adds 13 Drugs to Watch List
The US Food and Drug Administration (FDA) has released its latest list of drugs to monitor based on potential signs of serious risks or new safety information identified in the agency's Adverse Event Reporting System (AERS).
The quarterly watch list consists of 13 medications that treat a wide range of conditions, including cough, angina, diabetes, cancer, and bipolar disorder.
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