Content about Urinary bladder

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. 

October 22, 2012
Astellas bladder drug made available in U.S.

The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.

NORTHBROOK, Ill. — The U.S. subsidiary of Japanese drug maker Astellas Pharma has made a drug for overactive bladder available in U.S. pharmacies, the company said.

Astellas Pharma US announced the availability of Myrbetriq (mirabegron) extended-release tablets. The drug is used to treat OAB with symptoms of urge urinary incontinence, urgency and urinary frequency. The Food and Drug Administration approved the drug on June 28, 2012.

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.

August 3, 2012
Drug for overactive bladder effective in patients who haven't responded well to earlier therapy, study finds

A drug made by Pfizer and used to treat overactive bladder was effective in reducing leakage of urine in patients with the disorder, according to the results of a post-approval clinical study.

NEW YORK — A drug made by Pfizer and used to treat overactive bladder was effective in reducing leakage of urine in patients with the disorder, according to the results of a post-approval clinical study.

Pfizer announced Friday results of a phase-4 study of Toviaz (fesoterodine fumarate) in the reduction of urge urinary incontinence in patients with OAB who had a less than 50% reduction in UUI when taking Detrol LA (tolterodine tartrate), a commonly prescribed treatment for the condition also made by Pfizer.

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.

December 9, 2011
FDA approves Antares Pharma's overactive bladder drug

The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a topical gel made by Antares Pharma for overactive bladder.

Watson Pharmaceuticals announced Thursday the approval of oxybutynin gel in the 3% strength, which it will launch next year under a licensing agreement with Antares.

December 6, 2011
Pfizer's Toviaz safe, effective in treating overactive bladder in elderly patients

A drug made by Pfizer appears to work in treating overactive bladder in elderly patients, according to results of a clinical trial released Monday.

NEW YORK — A drug made by Pfizer appears to work in treating symptoms of overactive bladder in elderly patients, according to results of a clinical trial released Monday.

Pfizer said that results of study A0221049 of the drug Toviaz (fesoterodine fumarate) worked better than placebo in reducing the number of urgency urinary incontinence episodes. The 12-week study enrolled 562 elderly people in the United States. The drug already has Food and Drug Administration approval for treating overactive bladder.

August 5, 2010
Mission launches Uribel

Drug maker Mission Pharmacal has launched a treatment for urinary tract infections....

SAN ANTONIO Drug maker Mission Pharmacal has launched a treatment for urinary tract infections.

 

Mission announced the launch of Uribel (methenamine, sodium phosphate monobasic, phenyl salicylate, methylene blue and hyoscyamine sulfave) capsules, used to relieve local discomfort and inflammation associated with lower urinary tract infections, interstitial cystitis, painful bladder syndrome and urinary tract procedures.

 

 

March 23, 2010
SCA introduces Tena Ultra Thins

SCA Personal Care North America on Wedneseday introduced a new category of adult absorbent products...