Interstitial Cystitis

• EMA approval · 2026-08-04
  EMA Authorised: Elmiron (pentosan polysulfate sodium) — bene-Arzneimittel GmbH

  The EMA has authorised Elmiron (pentosan polysulfate sodium) for interstitial cystitis, with bene-Arzneimittel GmbH as the marketing authori…

• EMA approval · 2022-07-15
  EMA Authorised: Elmiron (pentosan polysulfate sodium) — bene-Arzneimittel GmbH

  European Medicines Agency authorises Elmiron (pentosan polysulfate sodium) for interstitial cystitis; marketing authorization holder bene-Ar…

• FDA approval · 2021-03-12
  FDA Approved: ELMIRON — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved Janssen's supplemental application for Elmiron (pentosan polysulfate sodium), updating its labeling and approved indications.

• FDA approval · 2015-08-27
  FDA Approved: RIMSO-50 — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for RimSO-50 (dimethyl sulfoxide) submitted by Mylan Institutional LLC.

• FDA approval · 2014-08-28
  FDA Approved: RIMSO-50 — Supplemental Application (Mylan Institutional LLC)

  FDA approved a supplemental application for RimSO-50 (dimethyl sulfoxide) submitted by Mylan Institutional LLC. The action pertains to the i…

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• FDA approval · 2013-06-26
  FDA Approved: RIMSO-50 — Supplemental Application (Mylan Institutional LLC)

  FDA approves a supplemental application for RimSO-50 (dimethyl sulfoxide) submitted by Mylan Institutional LLC.

• FDA approval · 2008-07-28
  FDA Approved: RIMSO-50 — Supplemental Application (Mylan Institutional LLC)

  The FDA approved a supplemental application for RimSO-50 (dimethyl sulfoxide) submitted by Mylan Institutional LLC.

• FDA approval · 2008-07-24
  FDA Approved: ELMIRON — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  FDA approved a supplemental application for ELMIRON (pentosan polysulfate sodium) submitted by Janssen Pharmaceuticals, Inc. The action upda…

• FDA approval · 2006-09-20
  FDA Approved: ELMIRON — Supplemental Application (Janssen Pharmaceuticals, Inc.)

  The FDA approved a supplemental application for ELMIRON (pentosan polysulfate sodium) from Janssen Pharmaceuticals, Inc.