Irritable Bowel Syndrome

• FDA label_change · 2017-11-08
  FDA Approved: VIBERZI — Supplemental Application (Allergan, Inc.)

  FDA approved Allergan's supplemental application for VIBERZI (eluxadoline), updating the labeling for this product.

• EMA label_change · 2017-06-23
  EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome

  EMA recommends that Symbioflor 2 can continue to be used for irritable bowel syndrome, indicating ongoing authorization status and review ou…

• FDA label_change · 2017-01-13
  FDA Approved: LIBRAX — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for Librax (chlordiazepoxide hydrochloride and clidinium bromide) submitted by Bausch Health US, LLC…

• FDA label_change · 2013-08-13
  FDA Approved: DICYCLOMINE HYDROCHLORIDE — Supplemental Application (Actavis Pharma, Inc.)

  FDA approved a supplemental application for dicyclomine hydrochloride, resulting in updated labeling for Actavis Pharma’s product.

• EMA label_change · 2009-12-31
  EMA Refused: Zelnorm (tegaserod) — Novartis Europharm Limited

  The EMA refused the marketing authorization for Zelnorm (tegaserod) by Novartis Europharm Limited for irritable bowel syndrome.

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