Nomination Summary for Elmiron (sodium pentosanpolysulfate) (N87313)
Nominated Substances: Elmiron (sodium pentosanpolysulfate)
Nomination Date: 06/17/1987
Nominator: FDA
Rationale: Drug has orphan drug status in the U.S. for the compassionate treatment of interstitial cystitis under the Food and Drug Administration (FDA) investigational New Drug procedure; potential for chronic use; currently marketed in several foreign countries.
NTP Principles: Pre 1993 - 2