Overactive Bladder

• FDA approval · 2017-12-08
  FDA Approved: DARIFENACIN — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved a generic version of darifenacin from Alembic Pharmaceuticals Limited as an original application. Darifenacin is used to treat …

• FDA approval · 2017-10-24
  FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)

  FDA approved a supplemental application for OXYTROL (oxybutynin) filed by Allergan, Inc. This decision updates the product labeling.

• FDA approval · 2017-10-23
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (ANI Pharmaceuticals, Inc.)

  FDA approved ANI Pharmaceuticals' Original Application for oxybutynin chloride as a generic product for overactive bladder and related urina…

• FDA approval · 2017-10-03
  FDA Approved: FESOTERODINE FUMARATE — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original abbreviated new drug application (ANDA) for fesoterodine fumarate (generic), manufactured by Zydus Pharmaceuticals…

• FDA approval · 2017-07-28
  FDA Approved: DARIFENACIN — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original application for darifenacin from Macleods Pharmaceuticals Limited, marking the approval of a generic formulation o…

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• FDA approval · 2017-06-26
  FDA Approved: OXYBUTYNIN — Original Application (Zydus Pharmaceuticals USA Inc.)

  FDA approved the original ANDA for oxybutynin from Zydus Pharmaceuticals USA Inc., authorizing a generic version of the drug.

• FDA approval · 2017-02-17
  FDA Approved: FESOTERODINE FUMARATE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's generic fesoterodine fumarate through an original ANDA for the treatment of overactive bladder.

• FDA approval · 2017-01-26
  FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)

  The FDA approved a supplemental application for TOVIAZ (fesoterodine fumarate) submitted by Pfizer Laboratories Div Pfizer Inc.

• FDA approval · 2017-01-05
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Accord Healthcare, Inc.)

  FDA approved a supplemental application for Accord Healthcare, Inc. to market oxybutynin chloride as a generic product.

• FDA approval · 2016-11-22
  FDA Approved: TOLTERODINE TARTRATE — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved an Abbreviated New Drug Application for tolterodine tartrate by Teva Pharmaceuticals USA, enabling a generic version for overac…

• FDA approval · 2016-11-17
  FDA Approved: DARIFENACIN — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved the original ANDA for Darifenacin from Torrent Pharmaceuticals Limited. Darifenacin is used to treat overactive bladder, includ…

• FDA approval · 2016-09-19
  FDA Approved: DARIFENACIN — Original Application (Rising Pharma Holdings, Inc.)

  FDA approved the original application for darifenacin (generic) by Rising Pharma Holdings, Inc. for the treatment of overactive bladder.

• FDA approval · 2016-09-01
  FDA Approved: DARIFENACIN — Original Application (Cipla USA Inc.)

  FDA approved the original ANDA for Darifenacin (darifenacin hydrobromide) from Cipla USA Inc., establishing a generic option for the treatme…

• FDA approval · 2016-08-23
  FDA Approved: TROSPIUM CHLORIDE — Original Application (CIPLA USA INC.,)

  The FDA approved Cipla USA's generic Trospium chloride via an Original Abbreviated New Drug Application (ANDA).

• FDA approval · 2016-08-01
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for MYRBETRIQ (mirabegron) by Astellas Pharma US, Inc.

• FDA approval · 2016-03-03
  FDA Approved: OXYTROL FOR WOMEN — Supplemental Application (Allergan, Inc.)

  FDA approval of a supplemental application for OXYTROL FOR WOMEN (oxybutynin) from Allergan, Inc. to modify or expand the product's regulato…

• FDA approval · 2016-02-29
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (Accord Healthcare, Inc.)

  FDA approved Oxybutynin Chloride as a generic product under an Original Application by Accord Healthcare, Inc., for the treatment of overact…

• FDA approval · 2015-12-10
  FDA Approved: FESOTERODINE FUMARATE — Original Application (Ascend Laboratories, LLC)

  The FDA approved the original application for fesoterodine fumarate (generic) manufactured by Ascend Laboratories, LLC, as a generic version…

• FDA approval · 2015-11-23
  FDA Approved: OXYBUTYNIN CHLORIDE — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal's original application for a generic oxybutynin chloride product.

• FDA approval · 2015-11-04
  FDA Approved: OXYBUTYNIN CHLORIDE — Supplemental Application (Chartwell RX, LLC)

  FDA supplemental approval for oxybutynin chloride submitted by Chartwell RX, LLC for an existing generic product.

• FDA approval · 2015-11-02
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for MYRBETRIQ (mirabegron) submitted by Astellas Pharma US, Inc.

• FDA approval · 2015-09-25
  FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for tolterodine tartrate submitted by Teva Pharmaceuticals USA, Inc. for a generic product.

• FDA approval · 2015-08-31
  FDA Approved: TOLTERODINE TARTRATE — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved Macleods Pharmaceuticals Limited's tolterodine tartrate as an original ANDA, enabling a generic tolterodine tartrate product fo…

• FDA approval · 2015-08-11
  FDA Approved: TOLTERODINE TARTRATE — Original Application (Torrent Pharmaceuticals Limited)

  FDA approved Torrent Pharmaceuticals Limited's original application for tolterodine tartrate (tolterodine), a generic treatment for overacti…

• FDA approval · 2015-08-10
  FDA Approved: MYRBETRIQ — Supplemental Application (Astellas Pharma US, Inc.)

  The FDA approved a supplemental application for MYRBETRIQ (mirabegron) submitted by Astellas Pharma US, Inc.