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Teva Pharma Gets FDA Approval For Epirubicin Hydrochloride Injection And Sildenafil Citrate TabletsTeva Pharmaceutical Industries Ltd. (TEVA), a pharmaceutical company, said that it has received final FDA approval for its Abbreviated New Drug Application or ANDA for Epirubicin Hydrochloride Injection, 2 mg/mL. The company has also received tentative FDA approval for its ANDA for Sildenafil Citrate Tablets, 20 mg The company said its Epirubicin Hydrochloride Injection is the AP-rated generic equivalent of Pfizer's Ellence Injection, a product indicated for use as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer Upon final approval, Sildenafil Citrate Tablets will be the AB-rated generic equivalent of Pfizer's Revatio Tablets, a product indicated for treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability | |
| 10 Aug, 2007 | http://www.rttnews.com/sp/breakingnews.asp?date=08/10/2007&item =137 |
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Sildenafil Produces Significant Haemodynamic Response in Patients With Pulmonary Arterial Hypertension Treated With Bosentan: Presented at ESCA single oral dose of sildenafil has beneficial haemodynamic effects when added to bosentan in patients with PAH pulmonary arterial hypertension (PAH), according to study results presented here at the European Society of Cardiology (ESC) Congress. Use of the phosphodiesterase type 5 inhibitor sildenafil raised no clinically relevant safety concerns and resulted in significant reductions in pulmonary vascular resistance (PVR) and total pulmonary resistance (TPR) in the international, multicentre, open-label, non-comparative, prospective Combination Bosentan and Sildenafil in PAH (COMPASS-1) study "Within the last 10 years, there has been a remarkable improvement in the treatment of pulmonary arterial hypertension, and there have been many different medical treatments developed," said the study's principal investigator for Germany, Ekkehard Gruenig, MD, Associate Professor and Head, Pulmonary Hypertension Unit, Thorax Clinic, University of Heidelberg, Heidelberg, Germany | |
| 6 Sep, 2007 | http://www.docguide.com/news/content.nsf/news/852571020057CCF68525734E0069D948 |
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