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Nomination Summary for Clarithromycin (N99022)

Nominated Substances: Clarithromycin

Nomination Date: 05/19/1999

Nominator: FDA

Rationale: Used in the treatment of mild to moderate infections caused by specific microorganisms. Hepatotoxicity, testicular atrophy, lymphoid depletion and renal tubular degeneration were observed in rats, dogs, and monkeys exposed to Clarithromycin. Lack of carcinogenicity data; current use patterns and rapid absorption and distribution into body tissues

NTP Principles: 2, 3, 7

Status: Selected

Agents and Status

The following information relates to the specific agent and may include history from earlier or later nominations for this same agent.

CASRN: 81103-11-9

Agent Name: Clarithromycin