FDAnews Drug Daily Bulletin

PAR'S GENERIC PARNATE RECEIVES FDA APPROVAL

July 13, 2006
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The FDA has approved Par Pharmaceutical's generic equivalent of GlaxoSmithKline's depression drug Parnate, the drugmaker said. Par will market the drug in 10-mg tablets.

Annual sales of Parnate (tranylcypromine sulfate) exceed $6 million, Par said.

Parnate was one of 11 antidepressants given a black box warning in January 2005 after the FDA approved labeling revisions to antidepressants to describe the increased risk of suicidal behavior in children and adolescents who take the drugs.