New US Drug Approvals Announced

8 September 1996

Despite it being the holiday period, a number of new drug products were cleared for marketing by the US Food and Drug Administration, or approval letters were sent to their originators early this month or late last month. The major approvals are as follows:

- Eli Lilly says that it received an approvable letter in support of its drug Zyprexa (olanzapine) for the treatment of the symptoms of psychotic disorders. Lilly says it was not asked to present its data at an FDA advisory board before receiving this notification. A New Drug Application on Zyprexa, which according to Lilly Research Laboratories' vice president Gary Tollefson "is one of the first compounds resulting from Lilly's increased commitment to developing new therapies for the treatment of psychosis," was filed September 21, 1995.

- EnviroDerm Pharmaceuticals has received clearance from the FDA to market IvyBlock, the first and only poison ivy, oak and sumac skin protectant. IvyBlock will be available in the USA without prescription.

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