Benign Prostatic Hyperplasia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2022-10-12FDA Approved: ALYQ — Original Application (Teva Pharmaceuticals, Inc.)
The FDA approved ALYQ as Teva's generic tadalafil in an original ANDA approval. The approval covers the same indications as tadalafil, inclu…
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FDA approval · 2022-09-23FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Apotex Corp.)
The FDA approved a supplemental application for Alfuzosin hydrochloride from Apotex Corp., approving changes related to this generic drug's …
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FDA approval · 2022-09-15FDA Approved: ALFUZOSIN HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Alfuzosin hydrochloride from Aurobindo Pharma Limited.
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CLINICAL_TRIALS trial_result · 2022-09-07Clinical Trial Update: Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia [Phase 2, Phase 3]
A phase 2/3 clinical trial update on a composite steep-pulse treatment device for benign prostatic hyperplasia has completed.
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CLINICAL_TRIALS trial_result · 2022-08-25Clinical Trial Update: Evaluate the Efficacy and Safety of GV1001 in Patients With Benign Prostatic Hyperplasia (BPH) [Phase 3]
Phase 3 clinical trial evaluating GV1001 for efficacy and safety in benign prostatic hyperplasia has completed.
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FDA approval · 2022-08-11FDA Approved: TADALAFIL — Original Application (Solco Healthcare US, LLC)
FDA approved an original ANDA for tadalafil tablets (generic tadalafil) by Solco Healthcare US, LLC. The product is approved for erectile dy…
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CLINICAL_TRIALS trial_result · 2022-08-10Clinical Trial Update: Efficacy of Tadalafil/Solifenacin VS Tamsulosin/Solifenacin Combination Therapy for BPH/OAB [Phase 4]
Phase 4 trial comparing tadalafil/solifenacin vs tamsulosin/solifenacin for BPH with concomitant overactive bladder; current status unknown.
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FDA approval · 2022-06-17FDA Approved: TADLIQ — Original Application (CMP Pharma, Inc.)
FDA approved CMP Pharma's TadliQ (tadalafil) under Original Application NDA214522, approving its use for erectile dysfunction and benign pro…
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FDA approval · 2022-06-07FDA Approved: FINASTERIDE — Supplemental Application (Teva Pharmaceuticals USA, Inc.)
The FDA approved a supplemental application for finasteride filed by Teva Pharmaceuticals USA, Inc.
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FDA approval · 2022-05-27FDA Approved: TADALAFIL — Supplemental Application (Aurobindo Pharma Limited)
The FDA approved a supplemental application for Tadalafil submitted by Aurobindo Pharma Limited. This action adds regulatory approval for th…
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CLINICAL_TRIALS trial_result · 2022-05-26Clinical Trial Update: Efficacy and Safety of a Single TRUS-guided Intraprostatic Injection of NX-1207 in Patients With LUTS Due to BPH [Phase 3]
Phase 3 trial update on NX-1207 intraprostatic injection for LUTS due to BPH; study terminated.
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FDA approval · 2022-05-24FDA Approved: SILODOSIN — Supplemental Application (Novadoz Pharmaceuticals LLC)
FDA approved a supplemental application for silodosin. The applicant is Novadoz Pharmaceuticals LLC.
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FDA approval · 2022-05-18FDA Approved: FINASTERIDE — Supplemental Application (Aurobindo Pharma Limited)
FDA approved a supplemental application for Finasteride submitted by Aurobindo Pharma Limited.
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FDA approval · 2022-05-18FDA Approved: TADALAFIL — Supplemental Application (Quallent Pharmaceuticals Health LLC)
The FDA approved a supplemental application for tadalafil from Quallent Pharmaceuticals Health LLC. This action concerns the approval of a g…
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FDA approval · 2022-05-05FDA Approved: FINASTERIDE — Supplemental Application (Dr Reddys Laboratories Inc)
FDA approved a supplemental application for finasteride from Dr Reddys Laboratories Inc., authorizing a generic Finasteride product.
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FDA approval · 2022-05-04FDA Approved: TAMSULOSIN HYDROCHLORIDE — Original Application (XLCare Pharmaceuticals, Inc)
FDA approved an original application for tamsulosin hydrochloride from XLCare Pharmaceuticals, Inc., authorizing a generic version of tamsul…
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CLINICAL_TRIALS trial_result · 2022-05-03Clinical Trial Update: Prostatic Artery Embolization Versus Medical Treatment in Symptomatic Benign Prostatic Hyperplasia [Phase 3]
Phase 3 trial comparing prostatic artery embolization to medical therapy for symptomatic benign prostatic hyperplasia has completed.
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CLINICAL_TRIALS trial_result · 2022-03-31Clinical Trial Update: To Determine the Effectiveness of Saddle Block vs Spinal Anesthesia in TURP [Phase 3]
Phase 3 trial evaluating saddle block versus spinal anesthesia in TURP has completed.
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CLINICAL_TRIALS trial_result · 2022-03-31Clinical Trial Update: A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial A Comparison of Traditional and MOSES Laser Enucleation of the Prostate (MOLEP): A Prospective, Randomized, Double-blinded Control Trial [Phase 3]
A Phase 3 randomized, double-blinded trial comparing traditional laser enucleation with MOSES MOLEP for benign prostatic hyperplasia; result…
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CLINICAL_TRIALS trial_result · 2022-03-22Clinical Trial Update: Efficacy of a Single Dose Dexamethasone in Reducing the Postembolization Syndrome in Men Undergoing Prostatic Artery Embolization for Benign Prostatic Hyperplasia [Phase 4]
Phase 4 trial evaluating whether a single dose of dexamethasone reduces postembolization syndrome after prostatic artery embolization for be…
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FDA approval · 2022-03-15FDA Approved: DOXAZOSIN — Original Application (Rising Pharma Holdings, Inc.)
FDA approved the original application for doxazosin (generic) by Rising Pharma Holdings, Inc., expanding access to this alpha-1 blocker for …
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FDA approval · 2022-03-11FDA Approved: FINASTERIDE — Supplemental Application (Ascend Laboratories, LLC)
FDA approved a supplemental application for finasteride from Ascend Laboratories, LLC, granting approval of a generic finasteride product un…
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FDA approval · 2022-03-11FDA Approved: FINASTERIDE — Supplemental Application (Camber Pharmaceuticals, Inc.)
FDA approved a supplemental application for Camber Pharmaceuticals to market a generic finasteride product, expanding access to the referenc…
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CLINICAL_TRIALS trial_result · 2022-03-04Clinical Trial Update: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of GV1001 in Patients With BPH [Phase 2]
A Phase II trial evaluating GV1001 for efficacy and safety in benign prostatic hyperplasia has been completed.
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CLINICAL_TRIALS trial_result · 2022-02-17Clinical Trial Update: To Evaluate the Feasibility, Preliminary Safety and Performance of Rezūm System in BPH Treatment in China
A completed clinical trial evaluating the feasibility, preliminary safety, and performance of the Rezūm System for Benign Prostatic Hyperpla…