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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.