None

Daiichi Sankyo launches silodosin for the treatment of dysuria in China

Daiichi Sankyo announced that its subsidiary, Daiichi Sankyo Pharmaceutical (Beijing) Co., Ltd., has begun marketing silodosin...

Japan briefs: Daiichi Sankyo launches silodosin in China; Fujifilm Diosynth UK unit commissioned

Japanese drug major Daiichi Sankyo (TYO: 4568) says that its subsidiary, Daiichi Sankyo Pharmaceutical (Beijing), has begun marketing silodosin (Chinese product name: ), which was developed for treatm...

FDA Approving More ANDAs That Use Novel Bioequivalence Methods

OGD officials report on the progress being made in approving generic drugs using more novel and science-based bioequivalence methods than in the past. Officials impart tips on how to submit review-rea...

RedHill bioequivalence trial with RHB-103 meets specified endpoints

RedHill Biopharma has announced positive results from a pivotal bioequivalence trial with RHB-103, an oral thin-film formulation of Rizatriptan for the treatment of acute migraine.

Silodosin is effective for treatment of LUTS in men with BPH: a systematic review

Generic Bupropion XL Reevaluation Running Behind Schedule

FDA has received data from just one of four bioequivalence studies of 300 mg bupropion extended-release generics it requested by March from sponsors following Impax/Teva’s withdrawal of their generi...

Azaya Therapeutics commences ATI-0918 bioequivalence study in ovarian cancer

Azaya Therapeutics, Inc. today announced the initiation of a bioequivalence study of ATI-0918 in patients with ovarian cancer.

Human medicines European Public Assessment Report (EPAR): Silodyx, silodosin, Revision: 6, Authorised

Short-term effects of crossover treatment with silodosin and tamsulosin hydrochloride for lower urinary tract symptoms associated with benign prostatic hyperplasia.

Objectives: To compare the efficacy and safety of silodosin and tamsulosin in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) by a randomized cross...

Symptomatic and urodynamic responses in patients with reduced or no seminal emission during silodosin treatment for LUTS and BPH.

Data from phase 3 studies (NCT00224107, NCT00224120) of silodosin for treatment of BPH symptoms were analyzed to examine the relationship between treatment efficacy and occurrence of abnormal ejaculat...

The efficacy and safety of silodosin in treating BPH: a systematic review and meta-analysis.

PURPOSE: Pharmacological therapy is typically the first-line treatment for patients with benign prostatic hyperplasia (BPH). We carried out a systematic review and meta-analysis to assess the efficacy...

Effects by silodosin on the partially obstructed rat ureter in vivo and on human and rat isolated ureters.

BACKGROUND AND PURPOSE: α(1) -adrenoceptor (-AR) antagonists may facilitate ureter stone passage in humans. We aimed to study effects by the α(1A) -AR selective antagonist silodosin (compared to tam...

Silodosin : a new subtype selective alpha-1 antagonist for the treatment of lower urinary tract symptoms in patients with benign prostatic hyperplasia.

Introduction: Silodosin is a new uroselective alpha-blocker with high pharmacological selectivity for the (1A) adrenoceptor. It is an effective and well-tolerated treatment in men with lower urinary t...