Meridia Needs Continued Intensive Monitoring For Pediatric Adverse Events
Pediatric adverse events associated with Abbott's weight-loss agent Meridia should be monitored more intensively for a second year, FDA's Pediatric Advisory Committee unanimously recommended
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Abbott's Meridia (sibutramine) will remain on the market after FDA denies Public Citizen's 2002 petition to withdraw the weight-loss drug. In its Aug. 9 FDL-1response, FDA acknowledges some risks associated with Meridia but says they can be addressed by Abbott's recently revised risk management program. The agency also disputes Public Citizen's use of AERS reports to support its argument that the fatality rate associated with Meridia is enough to warrant its withdrawal. Abbott's 9,000-patient long-term safety study (SCOUT) may address the issue; as of April, 8,000 patients had been enrolled (1"The Pink Sheet" June 25, 2001, p. 13)...
Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011
FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials