Overactive Bladder

• FDA label_change · 2021-03-25
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA has approved a supplemental application for MYRBETRIQ (mirabegron) from Astellas US, resulting in changes to the product labeling. The a…

• FDA label_change · 2017-11-12
  FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  FDA approved a supplemental labeling application for TOVIAZ (fesoterodine fumarate) from Pfizer.

• FDA label_change · 2017-07-28
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYRBETRIQ (mirabegron) submitted by Astellas Pharma US, updating the product labeling.

• FDA label_change · 2016-08-16
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for MYRBETRIQ (mirabegron) submitted by Astellas Pharma US, Inc., resulting in a label change for th…

• FDA label_change · 2014-07-28
  FDA Approved: DETROL LA — Supplemental Application (Viatris Specialty LLC)

  FDA approved a supplemental application for Detrol LA (tolterodine tartrate) submitted by Viatris Specialty LLC, resulting in labeling chang…

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• FDA label_change · 2013-07-10
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL (oxybutynin) from Allergan, Inc., resulting in changes to the product labeling. The acti…

• FDA label_change · 2013-03-29
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approves a supplemental labeling application for Vesicare (solifenacin succinate) from Astellas Pharma US, updating the drug's labeling.

• FDA label_change · 2012-08-03
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for VESICARE (solifenacin succinate) submitted by Astellas Pharma US, Inc.

• FDA label_change · 2012-07-13
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Vesicare (solifenacin succinate) submitted by Astellas Pharma US, updating the labeling for …

• FDA label_change · 2012-06-07
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Vesicare (solifenacin succinate) filed by Astellas Pharma US, Inc., resulting in a label change.

• FDA label_change · 2012-01-17
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for Vesicare (solifenacin succinate) submitted by Astellas Pharma US, Inc. to amend the product'…

• FDA label_change · 2011-03-10
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Vesicare (solifenacin succinate) by Astellas Pharma US, Inc., resulting in a label update.

• FDA label_change · 2008-11-18
  FDA Approved: VESICARE — Supplemental Application (Astellas Pharma US, Inc.)

  FDA approved a supplemental application for Vesicare (solifenacin succinate) from Astellas Pharma US, Inc., resulting in changes to the prod…