Benign Prostatic Hyperplasia
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS trial_result · 2022-02-08Clinical Trial Update: Pivotal Study to Assess the Safety and Effectiveness of the iTind Device [NA]
A pivotal study evaluating the safety and effectiveness of the iTind device for benign prostatic hyperplasia has completed, with results pos…
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CLINICAL_TRIALS trial_result · 2022-01-24Clinical Trial Update: Penthrox in Rezūm BPH [Phase 4]
Phase 4 trial update for Penthrox in Rezūm BPH has completed.
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FDA approval · 2022-01-03FDA Approved: SILODOSIN — Original Application (Creekwood Pharmaceuticals LLC)
FDA approves Creekwood Pharmaceuticals LLC's original application for silodosin. The drug is indicated for treatment of urinary symptoms due…
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FDA approval · 2021-11-22FDA Approved: SILODOSIN — Supplemental Application (Amneal Pharmaceuticals NY LLC)
FDA approved a supplemental application for silodosin from Amneal Pharmaceuticals NY LLC.
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CLINICAL_TRIALS trial_result · 2021-11-15Clinical Trial Update: Prostate Artery Embolization (PAE) for Lower Urinary Tract Symptoms (LUTS) Due to Benign Prostatic Hyperplasia (BPH) [NA]
Clinical trial update for Prostate Artery Embolization (PAE) treating lower urinary tract symptoms due to benign prostatic hyperplasia has c…
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CLINICAL_TRIALS trial_result · 2021-11-11Clinical Trial Update: Prostate Artery Embolization With Embosphere Microspheres Compared to TURP for Benign Prostatic Hyperplasia [NA]
Clinical trial comparing prostate artery embolization with Embosphere microspheres to TURP for benign prostatic hyperplasia; study terminate…
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FDA approval · 2021-11-04FDA Approved: TADALAFIL — Original Application (Burel Pharmaceuticals, LLC)
The FDA approved a generic tadalafil product under an original ANDA for Burel Pharmaceuticals, LLC.
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CLINICAL_TRIALS trial_result · 2021-10-15Clinical Trial Update: To Evaluate the Safety and Performance of the ProstaCare Water Electrolysis System in Relieving Symptoms of BPH. [NA]
A terminated clinical trial evaluated the safety and performance of the ProstaCare Water Electrolysis System for relieving symptoms of benig…
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CLINICAL_TRIALS trial_result · 2021-10-05Clinical Trial Update: Effectiveness of onaBoNT-A vs Oral Tamsulosin in Men With BPH and LUTS [Phase 2]
Phase 2 trial comparing onaBoNT-A to oral tamsulosin in men with benign prostatic hyperplasia and lower urinary tract symptoms has completed…
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FDA approval · 2021-09-15FDA Approved: TAMSULOSIN HYDROCHLORIDE — Supplemental Application (Sandoz Inc)
The FDA approved a supplemental application for tamsulosin hydrochloride (Sandoz Inc.), authorizing the continued marketing of the generic w…
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CLINICAL_TRIALS trial_result · 2021-08-27Clinical Trial Update: Efficacy of α-blocker or 5-ARI Withdrawal to Continued Combination Therapy on the Maintenance of LUTS in Men With BPH [Phase 3]
Phase 3 clinical trial evaluating withdrawal of α-blocker or 5-ARI to maintain combination therapy for lower urinary tract symptoms in men w…
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FDA approval · 2021-08-25FDA Approved: PROSCAR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for PROSCAR (finasteride) by Organon LLC, resulting in updates to the product's labeling under t…
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CLINICAL_TRIALS trial_result · 2021-08-10Clinical Trial Update: Minimally Invasive Prostatic Vapor Ablation for the Treatment of BPH in Large Prostates (Rezūm XL) [NA]
A terminated clinical trial evaluating minimally invasive prostatic vapor ablation (Rezūm XL) for BPH in large prostates; results were poste…
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CLINICAL_TRIALS trial_result · 2021-07-28Clinical Trial Update: Effects and Safety of OPK-88004 Doses in Men With Signs and Symptoms of Benign Prostatic Hyperplasia (BPH) [Phase 2]
Phase 2 trial update on OPK-88004 doses in men with Benign Prostatic Hyperplasia; study terminated with posted results.
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FDA label_change · 2021-07-16FDA Approved: SILODOSIN — Supplemental Application (Macleods Pharmaceuticals Limited)
FDA approved a supplemental application for Silodosin submitted by Macleods Pharmaceuticals Limited. The action updates the labeling for Sil…
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CLINICAL_TRIALS trial_result · 2021-07-16Clinical Trial Update: Prostatic Urethral Lift in Subject With Acute Urinary Retention [NA]
Completed clinical trial update for prostatic urethral lift in acute urinary retention with results posted.
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FDA approval · 2021-07-02FDA Approved: SILODOSIN — Supplemental Application (Ajanta Pharma USA Inc.)
The FDA approved Ajanta Pharma USA Inc.'s supplemental application for silodosin, enabling regulatory clearance related to the generic produ…
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FDA approval · 2021-07-02FDA Approved: SILODOSIN — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for a generic silodosin product from Aurobindo Pharma Limited. This action approves the generic …
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FDA approval · 2021-07-02FDA Approved: SILODOSIN — Supplemental Application (Alembic Pharmaceuticals Limited)
The FDA approved Alembic Pharmaceuticals Limited's supplemental application for silodosin, allowing a generic version to be marketed. The ap…
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FDA approval · 2021-07-02FDA Approved: SILODOSIN — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for silodosin under the ANDA206541, enabling the generic product's continued ma…
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FDA approval · 2021-06-23FDA Approved: DOXAZOSIN — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for doxazosin (doxazosin mesylate) from Mylan Pharmaceuticals. The drug is traditionally used to tre…
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FDA approval · 2021-06-22FDA Approved: CARDURA XL — Supplemental Application (Viatris Specialty LLC)
FDA has approved a supplemental application for CARDURA XL (doxazosin mesylate) submitted by Viatris Specialty LLC.
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FDA approval · 2021-06-15FDA Approved: PROSCAR — Supplemental Application (Organon LLC)
The FDA approved a supplemental application for PROSCAR (finasteride) submitted by Organon LLC.
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FDA approval · 2021-05-26FDA Approved: DUTASTERIDE — Supplemental Application (Epic Pharma, LLC)
FDA approved Epic Pharma's supplemental application to bring a generic dutasteride product to market for the treatment of benign prostatic h…
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CLINICAL_TRIALS trial_result · 2021-04-28Clinical Trial Update: Effect of 12 Weeks Treatment With Tadalafil vs Placebo on Lower Urinary Tract Symptoms [Phase 4]
Phase 4 clinical trial comparing tadalafil to placebo for lower urinary tract symptoms in men with prostatic hyperplasia has completed.