Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder
CORONA, Calif., May 28 /PRNewswire-FirstCall/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical
company, announced today that its New Drug Application (NDA) for oxybutynin
chloride topical gel (OTG), has been accepted for filing by the U.S. Food
and Drug Adminis...
Watson Launches GELNIQUE(TM) (oxybutynin chloride) Gel 10%, First and Only Topical Gel for Overactive Bladder (OAB)
...k-drying, clear and colorless, fragrance-free hydroalcoholic gel containing
oxybutynin chloride, an antispasmodic antimuscarinic agent. Applied once daily to the ...one-gram (approx. 1 mL) of GELNIQUE gel 10% delivers a consistent dose of
oxybutynin through the skin over a 24-hour period, providing strong efficacy with exce...
New Data Presented at AUA's Annual Conference Prove GELNIQUE(TM) (oxybutynin chloride) 10% gel is an Effective, Safe Option for Female Overactive Bladder (OAB) Patients
...clear and colorless, fragrance-free gel containing
oxybutynin hydrochloride that is developed and marketed by Wa...less, fragrance-free hydroalcoholic gel containing
oxybutynin chloride, an antispasmodic antimuscarinic agent. A...ELNIQUE consistently delivers a consistent dose of
oxybutynin through the skin over a 24-hour period, providing ...
Watson Pharmaceuticals Reports Third Quarter 2008 Results
...for the treatment of the signs and symptoms of benign
prostatic hyperplasia. The Company anticipates launching RAPAFLO in early
2009. Watson's NDA for
oxybutynin topical gel remains under review by FDA
for the treatment of overactive bladder and in the fourth quarter 2008,
Watson expects to have an NDA on file ...
Watson Receives US FDA Approval for RAPAFLO(TM) (silodosin) for the Treatment of Benign Prostatic Hyperplasia (BPH)
...val for RAPAFLO so quickly which
demonstrates, among other things, the high quality of our clinical and
regulatory groups," said Mr. Bisaro. "With our
oxybutynin gel NDA under
consideration with the FDA and plans to file our Trelstar(R) 6 month
application later this year, Watson is in a unique position to intr...
Mylan Reports Adjusted Diluted EPS of $0.16 for the Quarter Ended June 30, 2008
...an's domestic subsidiaries. Additionally, current
quarter margins were negatively impacted by competition on certain products
including amlodipine and
oxybutynin during the past twelve months.
The Company reported earnings from operations of $74.0 million for the
three months ended June 30, 2008. Excluding th...
Common Medications Could Cause Physical Impairment in the Elderly
...brand name Aricept), galantamine (Razadyne), rivastigmine (Exelon) and tacrine (Cognex).
About 10 percent of those studied were also taking either
oxybutynin or tolterodine, the two most commonly prescribed drugs for urinary incontinence.
"The two drugs are pharmacological opposites, which led us to hyp...
Dual treatment of incontinence and dementia associated with functional decline
... acetylcholine, a chemical that enhances communication between nerve cells in the brain.
About 10 percent of the residents were also taking either
oxybutynin or tolterodine, the two most commonly prescribed drugs for urinary incontinence. These drugs are known as anticholinergic agents and are designed to b...
FDA approves Watson Pharmaceuticals' Oxytrol patch
...active bladder. The patch called Oxytrol (generic:
oxybutynin transdermal system) reduces urinary urge incontine...ency, according to the drug's maker. Oral forms of
oxybutynin has been around for around 25 years but it has not...nd constipation. The patch delivers about 3.9mg of
oxybutynin per day through a transdermal delivery system i.e....
Oxybutynin in Medical Technology
Watson Announces Positive Results From Its Pivotal Study of Oxybutynin Topical Gel for the Treatment of Overactive Bladder
- Company on Target to File NDA in Second Quarter of 2008 -
CORONA, Calif., Jan. 7 /PRNewswire-FirstCall/ -- Watson
Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical
company, announced positive results today from its Phase 3 study of
oxybutynin topical gel (OTG) in ...
New, Published GELNIQUE Data Show Efficacy, Convenience and Excellent Tolerability
...clear and colorless, fragrance-free gel
containing
oxybutynin hydrochloride developed and marketed by Watson
(NY... 12 weeks. GELNIQUE delivers a
consistent dose of
oxybutynin through the skin over a 24-hour period. A
1- gram (approx. 1 mL) daily dose delivers about 4 mg
oxybutynin each day.
Patients applied GELNIQUE each day to ro...
Watson Announces Positive Data for Its New Investigational Products for Benign Prostatic Hyperplasia and Overactive Bladder
...ostate enlargement) and a
pharmacokinetic study of
oxybutynin chloride topical gel (OTG), an
investigational pro...oduces serum levels
similar to an already-approved
oxybutynin transdermal patch (Oxytrol(R)),
but demonstrates i...teady-State Pharmacokinetics of an
Investigational
oxybutynin Topical Gel in Comparison with Oxybutynin
Transder...
Watson Announces Silodosin NDA Accepted for Filing by FDA for the Treatment of Benign Prostatic Hyperplasia
...l cystitis; a six-month formulation of
Trelstar(R) (triptorelin pamoate for injectable suspension), for the
treatment of advanced prostate cancer; and
oxybutynin topical gel, for
overactive bladder.
For press releases and other company information, visit Watson
Pharmaceuticals' Web site at http://www.watson....
Oxybutynin in Biological Technology
Quantitation of Oxybutynin in Rabbit Plasma Using the Varian 1200L LC/MS/MS System
D Garteiz, TexMS Analytical Services, Houston, TX
Introduction
A Varian 1200L LC/MS/MS system was used for the quantitation of the plasma levels
oxybutynin obtained by topical delivery of therapeutic agents to the urinary tract using a urethra suppository mode of adm...
SEP Signs REGURIN(R) Deal
...Topfmeister P: Influences of
trospium chloride and
oxybutynin on quantitative EEG in healthy volunteers.
Eur J C... W: Effects of Tolterodine,
Trospium chloride, and
oxybutynin on the Central Nervous System. J Clin Pharm
41: 63...Topfmeister P: Influences of
trospium chloride and
oxybutynin on quantitative EEG in healthy volunteers.
Eur J C...
Watson's GELNIQUE(TM) (oxybutynin chloride) Gel 10% Approved by FDA for the Treatment of Overactive Bladder
...k-drying, clear and colorless, fragrance-free hydroalcoholic gel containing
oxybutynin chloride, an antispasmodic agent. Applied once daily to the thigh, abdomen,...ram (approx. 1 mL) dose of 100mg/g GELNIQUE delivers a consistent dose of
oxybutynin through the skin over a 24-hour period, providing strong efficacy without s...
Watson Pharmaceuticals Reports Second Quarter 2008 Results
...aro, Watson's President and Chief Executive Officer. "Our pipeline
products
oxybutynin topical gel for overactive bladder and silodosin for
BPH were well received...ng. Additionally, the FDA accepted our New Drug
Application for our topical
oxybutynin gel product and we successfully
launched MixJect(TM), our new delivery syst...
Watson Pharmaceuticals Reports Fourth Quarter and Full Year 2007 Results; Provides 2008 Outlook
...ication was accepted for filing by FDA on February 11, 2008.
The Company also recently completed the Phase 3 program on its topical gel
formulation of
oxybutynin for overactive bladder. Watson remains on track
to submit an NDA to FDA in mid 2008. Finally, Debiopharm, Watson's
development partner on Trelstar(R),...