Tamsulosin DRS is a new, proprietary, slow release oral granule formulation that addresses the large population of men who have benign prostatic hyperplasia (BPH) and who have dysphagia (difficulty swallowing tablets or capsules).
“FDA’s grant of the fee waiver frees up resources to further advance our drug development programs,” said
About Tamsulosin DRS (Tamsulosin HCl extended release for oral suspension)
Tamsulosin DRS is a new granule formulation containing the active pharmaceutical ingredient in FLOMAX® (tamsulosin HCI) capsules. FLOMAX® is indicated for the treatment of BPH also known as enlargement of the prostate. Tamsulosin is a selective alpha1 adrenoreceptor antagonist specific to receptors located in prostate and bladder smooth muscle. Symptoms associated with BPH occur because of a change in the functioning of the prostate and bladder smooth muscle that can lead to constricted urinary flow, urinary retention, urinary infection, kidney damage and a life-threatening blood infection called urosepsis. Blocking alpha1 adrenoreceptors relaxes smooth muscle resulting in improved urinary flow and reduction of BPH symptoms.
To help support these clinical development programs, the company markets and sells the PREBOOST® medicated individual wipe, which is a male genital desensitizing drug product for the prevention of premature ejaculation which is being co-promoted with
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Press Release Kari Sharp