Shire Adds Equetro To CNS Product Lineup
This article was originally published in The Pink Sheet Daily
Executive Summary
Extended-release carbamazepine clears FDA for treatment of bipolar disorder. In clinical trials, Equetro did not produce "significant weight gain or blood sugar changes," Shire says. Launch is expected in the first quarter of 2005.
You may also be interested in...
Lupus Guidance Suggests Broad Use Of Health-Related Quality Of Life Endpoint
FDA’s draft guidance on systemic lupus erythematosus drug development lists four possible claims that the agency “may be willing to approve”: reduction in disease activity; organ-specific lupus treatment; complete clinical response/remission; and reduction in flares.
RiskMAP Guidance Includes Plans For A Website
FDA is planning to develop a Risk Minimization Action Plan website, an agency risk management guidance states
Risk Management Guidance Suggests Using Claims Data To Evaluate Safety Signals
Three FDA risk management final guidances recommend that sponsors collect a wide range of safety data during both the clinical trial and postmarketing periods of drug development. The agency suggests that sponsors hold discussions with FDA before settling on drug study designs or postmarketing activities.