Daily Rules, Proposed Rules, and Notices of the Federal Government
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New drug application 020193 for Elmiron (pentosan polysulfate sodium) capsule was initially approved by FDA in September 1996. There are no approved ANDAs for this product. FDA is now issuing a draft guidance for industry on BE recommendations for generic pentosan polysulfate sodium capsule (Draft Pentosan Polysulfate Sodium Capsule BE Recommendations).
In March 2012, Janssen Pharmaceuticals, Inc. (Janssen), manufacturer of the reference listed drug (RLD), Elmiron, submitted (through its attorneys) a citizen petition requesting that FDA require that any ANDA referencing Elmiron meet certain conditions, including conditions related to demonstrating BE (Docket No. FDA-2012-P-0295). FDA is reviewing the issues raised in the petition. FDA will consider any comments on the Draft Pentosan Polysulfate Sodium Capsule BE Recommendations before responding to Janssen's citizen petition.
This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the Agency's current thinking on the design of BE studies to support ANDAs for pentosan polysulfate sodium capsule. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.
Interested persons may submit either written comments regarding this document to the Division of Dockets Management (see
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