Content about Overactive bladder

January 7, 2014

Mylan has launched a generic version of a drug made by Pfizer for treating bladder problems, the company said Tuesday.

PITTSBURGH — Mylan has launched a generic version of a drug made by Pfizer for treating bladder problems, the company said Tuesday.

Mylan announced the launch of tolterodine tartrate extended-release capsules in the 2-mg and 4-mg strengths. The drug is used to treat overactive bladder with symptoms of urinary incontinence, urgency and frequency.

The drug is a generic version of Pfizer's Detrol LA. Tolterodine tartrate extended-release capsules had sales of about $571.5 million during the 12-month period that ended in September, according to IMS Health.

September 26, 2013

Merck Consumer Care announced that Oxytrol for Women is now on shelf for the more than 20 million women suffering from overactive bladder.

WHITEHOUSE STATION, N.J. — Merck Consumer Care on Wednesday announced that Oxytrol for Women is now on shelf for the more than 20 million women suffering from overactive bladder. Oxytrol for Women is a thin, flexible patch that is discreetly applied to the abdomen, hip or buttock once every four days for the relief of overactive bladder in women. It is the first and only over-the-counter option that treats the OAB symptoms — urinary incontinence, urgency and frequency — which can take a physical and emotional toll on women.

August 8, 2013

The big news in incontinence is Oxytrol, which doesn't reach store shelves until September. It's a switched product coming from Merck Consumer Care that brings an entirely new indication to the over-the-counter space — overactive bladder in women.

The big news in incontinence is Oxytrol, which doesn't reach store shelves until September. It's a switched product coming from Merck Consumer Care that brings an entirely new indication to the over-the-counter space — overactive bladder in women.

Some analysts are hesitant to suggest a new OTC category will translate into blockbuster-style sales. However, overactive bladder is a lot like smoking cessation or weight loss in the sense that women don't necessarily discuss these symptoms with their doctors, according to the National Association for Continence.

July 3, 2013

Drug maker Impax Labs is hoping to become the first to market a generic version of a drug used to treat incontinence and overactive bladder, the company said Wednesday.

HAYWARD, Calif. — Drug maker Impax Labs is hoping to become the first to market a generic version of a drug used to treat incontinence and overactive bladder, the company said Wednesday.

May 29, 2013

The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic drug for incontinence made by Perrigo Co., the drug maker said Wednesday.

Perrigo announced the approval of trospium chloride extended-release capsules in the 60 mg strength, a once-daily treatment for overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug is a generic version of Allergan's Sanctura XR, which has annual sales of $54 million, according to Symphony Health Solutions.

January 25, 2013

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. 

November 29, 2012

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

PITTSBURGH — The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

Mylan announced the approval and launch of tolterodine tartrate tablets in the 1-mg and 2-mg strengths. The drug is a generic version of Detrol, made by Pharmacia and Upjohn, now owned by Pfizer.

Used to treat overactive bladder, tolterodine tartrate tablets had sales of about $61.5 million during the 12-month period ended in September, according to IMS Health.

November 15, 2012

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention.

SILVER SPRING, Md. — The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention. 

The committee voted five in favor and six opposed, also citing concerns that men might inappropriately choose to use the product as well. 

November 12, 2012

The PBM division of CVS Caremark is hoping to get patients to use lower-cost drugs for certain conditions by removing higher-cost drugs from its formulary, according to published reports.

NEW YORK — The PBM division of CVS Caremark is hoping to get patients to use lower-cost drugs for certain conditions by removing higher-cost drugs from its formulary, according to published reports.

The Wall Street Journal reported that CVS Caremark would stop covering 17 drugs starting on Jan. 1, 2013, after removing 30 this year. The drugs include Abbott's Androgel (testosterone gel) for low testosterone, and Pfizer's drug Detrol LA (tolterodine tartrate) for overactive bladder.

October 22, 2012

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 6, 2012

Kalorama Information on Thursday reported that a number of Rx-to-OTC switch applications currently are under review by the Food and Drug Administration across several new-to-self-care categories, including overactive bladder, bacterial infections, cholesterol and high blood pressure.

NEW YORK — Kalorama Information on Thursday reported that a number of Rx-to-OTC switch applications currently are under review by the Food and Drug Administration across several new-to-self-care categories, including overactive bladder, bacterial infections, cholesterol and high blood pressure.

September 4, 2012

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

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

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.

April 6, 2012

A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

DEERFIELD, Ill. — A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

The drug maker announced that the FDA Reproductive Health Drugs Advisory Committee voted 7-4 with one abstention that its assessment of the risks and benefits of the drug YM178 (mirabegron) supported the drug's approval.

The FDA is not required to follow the recommendations of advisory committees, but usually does. The agency is expected to decide whether or not to approve the drug by June 29.

April 4, 2012

A court has ruled that patents covering a drug used for overactive bladder are invalid, a company looking to launch a generic version of the drug said.

PARSIPPANY, N.J. — A court has ruled that patents covering a drug designed to treat an overactive bladder are invalid, a company looking to launch a generic version of the drug said.

Watson Pharmaceuticals said the U.S. District Court for the District of Delaware ruled that five patents covering Allergan's Sanctura XR (trospium chloride) extended-release capsules were invalid. Watson's application with the Food and Drug Administration for a generic version are pending, the company said.

December 9, 2011

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

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.

September 23, 2010

Drug maker Warner Chilcott will buy the U.S. rights to a treatment for overactive bladder...

ARDEE, Ireland Drug maker Warner Chilcott will buy the U.S. rights to a treatment for overactive bladder for $400 million, the company said Friday.

 

The drug maker announced that it would terminate its co-promotion agreement with Novartis concerning the drug Enablex (darifenacin) and purchase the rights to sell it in the United States. It may be required to make additional milestone payments of up to $20 million to Novartis.