Regulatory Focus™ > News Articles > FDA Releases New Bioequivalence Draft Guidance for Elmiron

FDA Releases New Bioequivalence Draft Guidance for Elmiron

Posted 21 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has released a new draft guidance on bioequivalence (BE) recommendations for pentosan polysulfate sodium capsules, the latest in a long line of drug-specific BE recommendations that seek to inform sponsors of the best way to conduct testing in support of an Abbreviated New Drug Application (ANDA).

Under existing federal regulations, sponsors looking to support the approval of a generic drug must show a drug is, within certain acceptable parameters, bioequivalent to the Orange Book reference listed drug (RLD). Drugs that are bioequivalent exhibit the same rate and extent of absorption, though minor differences may exist if they are proven to not have any effect on patients.

The drug, more commonly known by its branded name, Elmiron, was approved by FDA in 1996 and is marketed by Janssen Pharmaceuticals for the treatment of several bladder conditions, including the relief of bladder pain.

Copies of the draft guidance are not yet available online, but FDA said that physical copies are available through the agency. Comments on the draft guidance are due by 19 November 2012.


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