Overactive Bladder
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Sign up freeTop drugs studied for this disease
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FDA approval · 2025-11-04FDA Approved: MIRABEGRON — Original Application (Amneal Pharmaceuticals NY LLC)
The FDA approved Amneal Pharmaceuticals NY LLC's generic Mirabegron for the treatment of overactive bladder.
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EMA approval · 2025-09-15EMA Authorised: Emselex (darifenacin hydrobromide) — pharmaand GmbH
The EMA authorised Emselex (darifenacin hydrobromide) for urinary incontinence due to urge and overactive bladder, with pharmaand GmbH as th…
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EMA approval · 2025-08-27EMA Authorised: Betmiga (Mirabegron) — Astellas Pharma Europe B.V.
The European Medicines Agency authorised Betmiga (mirabegron) from Astellas Pharma Europe B.V. for the treatment of overactive bladder (auth…
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FDA approval · 2025-08-21FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Torrent Pharmaceuticals Limited)
The FDA approved a supplemental application for Tolterodine tartrate (tolterodine) submitted by Torrent Pharmaceuticals Limited, confirming …
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EMA approval · 2025-07-08EMA Authorised: Obgemsa (vibegron) — Pierre Fabre Medicament
EMA has authorised Obgemsa (vibegron) for overactive bladder and urinary incontinence. The marketing authorization holder is Pierre Fabre Me…
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FDA approval · 2025-06-30FDA Approved: MIRABEGRON — Original Application (Qilu Pharmaceutical Co., Ltd.)
The FDA approved Qilu Pharmaceutical Co., Ltd.'s generic mirabegron (ANDA 217989) for overactive bladder.
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FDA approval · 2025-06-17FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for tolterodine tartrate submitted by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2025-05-21FDA Approved: DARIFENACIN — Supplemental Application (Torrent Pharmaceuticals Limited)
FDA approved a supplemental application for Darifenacin from Torrent Pharmaceuticals Limited, expanding access to this overactive bladder th…
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EMA approval · 2025-04-08EMA Authorised: Kentera (previously Oxybutynin Nicobrand) (oxybutynin) — Teva B.V.
The European Medicines Agency authorised Kentera, a transdermal oxybutynin patch by Teva B.V., for urinary incontinence associated with urge…
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FDA approval · 2025-04-04FDA Approved: TROSPIUM CHLORIDE — Supplemental Application (Glenmark Pharmaceuticals Inc., USA)
FDA approved a supplemental application for trospium chloride from Glenmark Pharmaceuticals Inc., USA, granting a supplemental approval for …
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FDA approval · 2025-04-02FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved Camber Pharmaceuticals' supplemental application for fesoterodine fumarate (ANDA 204792).
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EMA approval · 2025-03-04EMA Authorised: Toviaz (fesoterodine fumarate) — Pfizer Europe MA EEIG
The EMA authorised Toviaz (fesoterodine fumarate) for the treatment of overactive bladder, with Pfizer Europe MA EEIG as the marketing autho…
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FDA approval · 2024-12-18FDA Approved: GEMTESA — Supplemental Application (Sumitomo Pharma America, Inc.)
The FDA approved a supplemental application for GEMTESA (vibegron) submitted by Sumitomo Pharma America, Inc.
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FDA approval · 2024-12-12FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for fesoterodine fumarate submitted by Camber Pharmaceuticals, Inc. under ANDA 204792. The action ap…
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FDA approval · 2024-11-04FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application from Aurobindo Pharma Limited for fesoterodine fumarate, authorizing the marketing of a generic vers…
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FDA approval · 2024-11-04FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Amneal Pharmaceuticals LLC)
The FDA approved a supplemental application for Amneal's fesoterodine fumarate, a generic version of the overactive bladder medication.
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FDA approval · 2024-10-08FDA Approved: GEMTESA — Supplemental Application (Sumitomo Pharma America, Inc.)
FDA approved a supplemental application for GEMTESA (vibegron) submitted by Sumitomo Pharma America, Inc., resulting in updated labeling.
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FDA approval · 2024-08-27FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Dr.Reddy's Laboratories Inc.,)
FDA approved a supplemental application for fesoterodine fumarate from Dr. Reddy's Laboratories, indicating regulatory approval of a modific…
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FDA approval · 2024-08-27FDA Approved: TOLTERODINE TARTRATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)
The FDA approved a generic tolterodine tartrate product (ANDA 216917) from Unichem Pharmaceuticals (USA), Inc. for the treatment of overacti…
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FDA approval · 2024-07-26FDA Approved: FESOTERODINE FUMARATE — Supplemental Application (Alembic Pharmaceuticals Inc.)
The FDA approved a supplemental application for fesoterodine fumarate submitted by Alembic Pharmaceuticals Inc. Fesoterodine fumarate is use…
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FDA approval · 2024-05-29FDA Approved: OXYTROL — Supplemental Application (Allergan, Inc.)
The FDA approved a supplemental application for OXYTROL (oxybutynin) by Allergan, Inc.
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FDA approval · 2024-02-28FDA Approved: TOVIAZ — Supplemental Application (Pfizer Laboratories Div Pfizer Inc)
The FDA approved a supplemental application for Toviaz (fesoterodine fumarate) from Pfizer Laboratories Div Pfizer Inc.
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FDA approval · 2024-02-20FDA Approved: SOLIFENACIN SUCCINATE — Original Application (Macleods Pharmaceuticals Limited)
FDA approved the original application for solifenacin succinate (Macleods Pharmaceuticals Limited), a generic version for the treatment of o…
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FDA approval · 2024-01-09FDA Approved: FESOTERODINE FUMARATE — Original Application (Camber Pharmaceuticals, Inc.)
FDA approves Camber Pharmaceuticals' original application for fesoterodine fumarate (generic), enabling its marketing for overactive bladder…
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FDA approval · 2023-06-07FDA Approved: TOLTERODINE TARTRATE — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Tolterodine Tartrate (generic) submitted by Macleods Pharmaceuticals Limited.