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Find Clinical Drug Development Pipelines & Deals | PipelineProspector
Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets, a muscarinic antagonist indicated for the treatment of overactive bladder.
The FDA approval is based on data from a randomized, double-blind Phase 3 study evaluating the safety and efficacy of BOTOX® in more than 100 pediatric patients with neurogenic detrusor overactivity and a long-term extension study.
Strides Pharma Global has received approval for Oxybutynin Chloride Tablets USP, 5 mg from the USFDA. Oxybutynin Chloride is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Ditropan Tablets, 5 mg, of Janssen Pharmaceuticals, Inc.
The combined company will focus on the R&D and commercialization of proprietary science and technologies for therapeutics, including Entadfi, a once-daily, oral treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.
CDSCO has approved Silodosin (selective alpha1A-adrenergic receptor antagonist) + Tadalafil (PDE5 inhibitor), a fixed dose combination for the treatment of benign prostatic hyperplasia.
Under the collaboration, Blue Water Biotech and IQVIA will market Blue Water’s commercial portfolio including, Entadfi, an FDA-approved, once daily pill that combines finasteride and tadalafil for benign prostatic hyperplasia and Zontivity (vorapaxar).
Solifenacin Succinate is a muscarinic receptor antagonist and tamsulosin is an alpha-1A and alpha-1B adrenergic receptor antagonist used in combination to treat benign prostatic hyperplasia.
The acquisition transforms the Company into a broader pharmaceutical company spanning multiple sectors by including ENTADFI (finasteride), an oral, once daily treatment for BPH that combines finasteride, a 5α-reductase inhibitor, and tadalafil, a PDE5 inhibitor.
KYORIN will grant Sumitomo Pharma the exclusive rights to develop, manufacture, and commercialize the therapeutic agent for OAB called Vibegron in in Taiwan and Other Asian Countries, and Sumitomo Pharma will develop, manufacture, and commercialize the Compound.
Solifenacin succinate is a muscarinic 3 receptor antagonist which works to decrease bladder activity by inhibiting contraction of the smooth muscle wall surrounding the bladder.
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