Benign Prostatic Hyperplasia
📧 Sign up to get email alerts when something new happens for Benign Prostatic Hyperplasia.
Sign up freeTop drugs studied for this disease
-
FDA approval · 2026-03-18FDA Approved: PROSCAR — Supplemental Application (Organon LLC)
FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.
-
FDA approval · 2026-01-26FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for Finasteride submitted by Teva Pharmaceuticals USA, Inc.
-
FDA approval · 2025-11-18FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (XLCare Pharmaceuticals, Inc)
FDA approved a supplemental application for Tamsulosin hydrochloride from XLCare Pharmaceuticals, Inc.
-
FDA approval · 2025-11-12FDA Approved: ALFUZOSIN HYDROCHLORIDE EXTENDED RELEASE — Supplemental Application (Cipla USA Inc.)
FDA approves a supplemental application for Alfuzosin hydrochloride extended-release from Cipla USA Inc., authorizing changes to the approve…
-
FDA approval · 2025-06-17FDA Approved: FINASTERIDE — Supplemental Application (Dr. Reddy's Laboratories Limited)
FDA approved a supplemental application for Finasteride submitted by Dr. Reddy's Laboratories Limited.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2025-06-17FDA Approved: FINASTERIDE — Supplemental Application (Accord Healthcare, Inc.)
FDA approved a supplemental application for Finasteride from Accord Healthcare, Inc. under the ANDA program. This product is indicated for b…
-
EMA approval · 2025-05-07EMA Authorised: Urorec (silodosin) — Recordati Ireland Ltd
EU marketing authorization has been granted for Urorec (silodosin) to treat benign prostatic hyperplasia. The marketing authorization holder…
-
EMA approval · 2025-03-14EMA Authorised: Silodyx (silodosin) — Recordati Ireland Ltd
The European Medicines Agency authorised Silodyx (silodosin) by Recordati Ireland Ltd for the treatment of benign prostatic hyperplasia. EU …
-
EMA approval · 2025-03-10EMA Authorised: Silodosin Recordati (silodosin) — Recordati Ireland Ltd
The EMA authorised Silodosin Recordati for the treatment of benign prostatic hyperplasia.
-
FDA approval · 2025-02-19FDA Approved: TADALAFIL — Supplemental Application (Alembic Pharmaceuticals Inc.)
FDA approved a supplemental application for tadalafil from Alembic Pharmaceuticals Inc., enabling a generic tadalafil product. The approval …
-
FDA approval · 2024-11-14FDA Approved: DUTASTERIDE — Supplemental Application (MARKSANS PHARMA LIMITED)
The FDA approved a supplemental application for a generic version of dutasteride from Marksans Pharma Limited. This approval supports the pr…
-
FDA approval · 2024-10-23FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Sun Pharmaceutical Industries, Inc.)
FDA approved Sun Pharmaceutical's supplemental application for alfuzosin hydrochloride.
-
FDA approval · 2024-09-27FDA Approved: DOXAZOSIN — Supplemental Application (Apotex Corp.)
FDA approved a supplemental application from Apotex Corp. for doxazosin, a generic product, likely updating labeling or manufacturing detail…
-
FDA approval · 2024-08-22FDA Approved: TADALAFIL — Supplemental Application (Teva Pharmaceuticals, Inc.)
FDA approved Teva Pharmaceuticals' supplemental application for tadalafil, updating the approved product.
-
FDA approval · 2024-08-16FDA Approved: SILODOSIN — Supplemental Application (Camber Pharmaceuticals, Inc.)
The FDA approved Camber Pharmaceuticals' supplemental application for silodosin.
-
FDA approval · 2024-07-29FDA Approved: TEZRULY — Original Application (ANI Pharmaceuticals, Inc.)
The FDA approved TEZRULY (terazosin) under ANI Pharmaceuticals' original NDA, bringing terazosin to market under a new brand for approved in…
-
FDA approval · 2024-07-18FDA Approved: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)
FDA approved Aurobindo Pharma Limited's Dutasteride and Tamsulosin Hydrochloride as an original generic combination product.
-
FDA approval · 2024-05-09FDA Approved: DOXAZOSIN — Supplemental Application (Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.)
FDA approved a supplemental application for doxazosin from Heritage Pharmaceuticals (d/b/a Avet Pharmaceuticals Inc.). The action updates th…
-
FDA approval · 2024-03-01FDA Approved: DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Zydus Pharmaceuticals USA Inc.)
FDA approved a supplemental application for the combination product Dutasteride and Tamsulosin Hydrochloride from Zydus Pharmaceuticals USA …
-
FDA approval · 2024-01-19FDA Approved: TERAZOSIN — Supplemental Application (Bionpharma Inc.)
The FDA approved a supplemental application for Terazosin from Bionpharma Inc., marking an update to the product's approval.
-
FDA approval · 2024-01-10FDA Approved: DOXAZOSIN MESYLATE — Original Application (Unichem Pharmaceuticals (USA), Inc.)
FDA approved the generic doxazosin mesylate from Unichem Pharmaceuticals (USA), Inc. under an Original Abbreviated New Drug Application, for…
-
FDA approval · 2023-11-02FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (EXELAN PHARMACEUTICALS, INC.)
The FDA approved a supplemental application for tamsulosin hydrochloride (Exelan Pharmaceuticals), granting approval for changes described i…
-
FDA approval · 2023-10-10FDA Approved: DUTASTERIDE — Supplemental Application (XLCare Pharmaceuticals, Inc.)
The FDA approved a supplemental application for dutasteride filed by XLCare Pharmaceuticals, Inc., resulting in updated labeling.
-
FDA approval · 2023-10-10FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for finasteride submitted by Ascend Laboratories, LLC, resulting in an approved change to the produc…
-
FDA approval · 2023-09-26FDA Approved: DOXAZOSIN — Supplemental Application (Accord Healthcare Inc.)
FDA approved a supplemental application for doxazosin from Accord Healthcare Inc., indicating an update to the approved generic product unde…