You are here

Mefloquine Hydrochloride Tablets Approved by FDA

WOODCLIFF LAKE, N.J., Dec. 30 /PRNewswire-FirstCall/ -- Barr Laboratories, Inc. today announced that it has received approval from the U.S. Food & Drug Administration (FDA) for Mefloquine Hydrochloride Tablets, 250 mg, the generic equivalent of Hoffman LaRoche, Inc.'s Lariam® Tablets. The Company plans to launch the product in early January 2004.

Barr's Mefloquine Hydrochloride Tablets are indicated for the prophylaxis of and treatment of mild to moderate acute malaria caused by mefloquine-susceptible strains of P. falciparum or by plasmodium vivax. Mefloquine should not be prescribed for prophylaxis in patients with psychiatric disorders or depression, and may cause psychiatric symptoms in some patients. Barr's product will compete in a market that had sales of approximately $38.2 million for the twelve months ended October 2003.

Source: Barr Laboratories, Inc.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug