GlaxoSmithKline Malarone revised labeling
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Labeling supplement approved Aug. 2 adds safety data on GSK's Malarone (atovaquone/proguanil) showing fewer adverse events than other antimalarials. Studies on prophylactic use in non-immune travelers, conducted to address Phase IV commitments, show significantly fewer neuropsychiatric side effects for Malarone than for Roche's Lariam (mefloquine), 14% vs. 29%, and fewer gastrointestinal events than chloroquine/proguanil, 12% vs. 20%. Pharmacokinetic information for special populations (geriatric, hepatic impairment) is also added to labeling. Malarone was approved July 14, 2000, for the treatment and prophylaxis of Plasmodium faciparum malari
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Labeling supplement approved Aug. 2 adds safety data on GSK's Malarone (atovaquone/proguanil) showing fewer adverse events than other antimalarials. Studies on prophylactic use in non-immune travelers, conducted to address Phase IV commitments, show significantly fewer neuropsychiatric side effects for Malarone than for Roche's Lariam (mefloquine), 14% vs. 29%, and fewer gastrointestinal events than chloroquine/proguanil, 12% vs. 20%. Pharmacokinetic information for special populations (geriatric, hepatic impairment) is also added to labeling. Malarone was approved July 14, 2000, for the treatment and prophylaxis of Plasmodium faciparum malaria |