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It is clear that the panel felt that there was inadequate data on the psychiatric implications of rimonabant. It is a strong statement coming in the wake of the rosiglitazone mess (with strong recollections of cerivastatin and Vioxx) demonstrating that the FDA will be very finicky about approvals in...
It is clear that the advisory panel is more concerned with safety in a limited population that the broader impact of obesity and its metabolic problems and acceleration of diabetes and atherosclerosis. This demonstrates the likelihood that the FDA will likely be posturing to reflect the rosiglitazone...
Implications: • The clinical trial experience with combination Altace plus hydrochlorothiazide (HCT) indicates safety and efficacy satisfactory for FDA approval. • The combination of ACE inhibitor and thiazide is old and ho-hum, and not as novel as newer combinations like Exforge (Novartis)....
Exforge (valsartan/amlodipine) is likely to be well received by physicians who have been fond of Lotrel and prefer branded hypertensive therapies to generic agents.
Implications: Clinical trial results indicate that Nebivolol is a safe and effective antihypertensive agent.As a vasodilating beta-1 selective beta blocker, Nebivolol could compete successfully against long-acting carvedilol and metoprolol.To compete successfully, Nebivolol will have to gain approval...
Avandia showed significantly higher risk for MI and CV death in meta-analysis and will likely be pulled from the market. We need CV outcome studies before approval for chronic disease drugs for HTN, DM, and dyslipidemia..
An NDA for Regadenoson has been submitted this week. The compound has a few significant benefits over adenosine: 1- bolus vs. 4 minute drip 2- Fewer symptoms. The compound has been shown to lead to essentially identical stress images. The drug will be marketed by Astellas who will push hard to switch...