GlaxoSmithKline Malarone revised labeling
This article was originally published in Pharmaceutical Approvals Monthly
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
You may also be interested in...
Pear Therapeutics’ Somryst insomnia treatment tool has become the first FDA-cleared product that was reviewed through the agency’s Software Precertification Pilot Program.
CNS specialist Neuraxpharm has struck a deal with Israel’s Panaxia to market medical cannabis products in Europe, starting in Germany.
The AAM has warned the Trump administration that ‘Buy American’ requirements on medicines could limit patient access to affordable medicines and increase the risk of drug shortages during the coronavirus pandemic.