Content about Urination

January 25, 2013
Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November. 

September 4, 2012
FDA's Nonprescription Drugs Advisory Committee to meet on Oxytrol Rx-to-OTC switch

According to a Food and Drug Administration post Friday, the FDA's Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system), as submitted by MSD Consumer.

SILVER SPRING, Md. — According to a Food and Drug Administration post Friday, the FDA's Nonprescription Drugs Advisory Committee will be meeting Nov. 9 regarding the partial switch application from prescription to over the counter of Oxytrol (oxybutynin transdermal system) submitted by MSD Consumer. The proposed OTC product would be called Oxytrol for Women and would be indicated for the treatment of overactive bladder in women.

The prescription form of Oxytrol is licensed by Watson Pharma.

June 28, 2012
FDA approves overactive bladder drug made by Astellas

The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for treating overactive bladder made by Astellas Pharma, the agency said Thursday.

The FDA announced the approval of Myrbetriq (mirabegron), which works by relaxing the bladder muscle while the organ is filling. In patients with overactive bladder, the muscle can't be controlled, squeezes too often or squeezes without warning. Symptoms of overactive bladder include the need to urinate too often, the need to urinate immediately and incontinence. The condition affects about 33 million Americans.

May 18, 2011
Rapaflo reduces CP/CPPS symptoms, improves outcomes among men in mid-stage trial

A branded drug made by Watson Pharmaceuticals reduced symptoms in men with prostate disease, according to results of a mid-stage clinical trial.

WASHINGTON — A branded drug made by Watson Pharmaceuticals reduced symptoms in men with prostate disease, according to results of a mid-stage clinical trial.

Data from the phase-2 study of the drug Rapaflo (silodosin) presented at the American Urological Association’s annual meeting showed that it reduced symptoms and improved outcomes in men with chronic prostatitis/pelvic pain syndrome, also known as CP/CPPS.