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