December 17, 2009
The FDA and The Medicines Company have notified healthcare professionals of a voluntary nationwide recall of 11 lots of Cleviprex (clevidipine butyrate) injection emulsion due to the presence of visible particulate matter observed in some vials.
December 07, 2009
Tris Pharma announced that the FDA has approved Clonidine ER suspension and Clonidine ER tablets, both of which utilize its proprietary OralXR+ platform technology to allow for once daily dosing.
October 19, 2009
The FDA has approved Twynsta (telmisartan/amlodipine tablets, from Boehringer Ingelheim) for the treatment of hypertension alone or in combination with other antihypertensives, or as initial therapy for patients who are likely to need multiple drugs to achieve their blood pressure goals.
October 19, 2009
The FDA has approved Micardis 80mg (telmisartan tablets, from Boehringer Ingelheim), an angiotensin II receptor blocker (ARB), for the reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients ≥55 years of age at high risk of developing major cardiovascular events who are unable to take angiotensin-converting enzyme inhibitors (ACE inhibitors).
September 18, 2009
The FDA has approved Valturna (aliskiren and valsartan tablets, from Novartis), a combination agent containing a direct renin inhibitor and an angiotensin receptor blocker, for the treatment of high blood pressure in patients not adequately controlled on aliskiren or angiotensin receptor blocker (ARB) monotherapy and as initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals.