Navigation Links
Watson Pharmaceuticals Receives a Complete Response Letter for Its 24-Week Formulation of TRELSTAR(R) (triptorelin pamoate) NDA from US FDA

MORRISTOWN, N.J., July 14 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, announced today that it received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for TRELSTAR(R) 22.5 mg (triptorelin pamoate for injectable suspension), a 24-week formulation of TRELSTAR(R) for the palliative treatment of advanced prostate cancer. The TRELSTAR(R) NDA was prepared in cooperation with Debiopharm Group, a Swiss-based global biopharmaceutical group of companies.

According to the letter, the FDA has requested clarifications related to the clinical testing of the product, additional information regarding the chemistry, manufacturing and controls (CMC) of the product and other components, and information related to third party manufacturing. Watson is working to ensure the requested information is provided to the FDA expeditiously.

TRELSTAR(R) 22.5 mg builds on Watson's long-standing track record in prostate cancer and expanding urology franchise. The new, longer-acting formulation of TRELSTAR(R) is designed to be conveniently administered and to continuously suppress the production of testosterone in men with advanced prostate cancer for 24 weeks. TRELSTAR(R) is an already proven therapy with established efficacy and safety in two formulations - a four-week formulation (TRELSTAR(R) DEPOT) and a 12-week formulation (TRELSTAR(R) LA).


TRELSTAR(R), developed by Debiopharm Group and marketed by Watson, administers a synthetic luteinizing hormone releasing hormone (LHRH) agonist, triptorelin, which suppresses the production of testosterone in the testicles. Prostatic cancer proliferation is regulated in part by the level and activity of testosterone. TRELSTAR(R) is currently available in a four-week depot formulation (TRELSTAR(R) DEPOT) and a 12-week long-acting formulation (TRELSTAR(R) LA), offering an alternative treatment for prostate cancer when orchiectomy (removal of the testicles) or estrogen administration are either not indicated or unacceptable to the patient. TRELSTAR(R) does not require refrigeration and should be stored at controlled room temperature.

Important Safety Information

In clinical trials, the most common adverse events occurring in patients were hot flushes, skeletal pain, impotence and headache. As with all LHRH agonists, triptorelin causes an initial transient increase in testosterone levels and may initiate or worsen symptoms during this transient period. Rare post-marketing reports of anaphylactic shock and angioedema have been reported. TRELSTAR(R) is contraindicated for use in women.

About Watson Pharmaceuticals, Inc.

Watson Pharmaceuticals, Inc., is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of brand pharmaceuticals focused on Urology, Women's Health and Nephrology/Medical.

For press release and other company information, visit Watson Pharmaceuticals' Web site at

About Debiopharm Group

Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses promising biological and small molecule drug candidates. It develops its products for global registration and maximum commercial potential. Once registered, the products are out-licensed to pharmaceutical partners for sales and marketing.

Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs.

Founded in 1979 and headquartered in Lausanne, Switzerland, Debiopharm has developed four products with global combined sales of $2.6 billion in 2008.

For more information on Debiopharm Group, please visit:

Forward-Looking Statement

Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; the difficulty of predicting the timing or outcome of FDA or other regulatory agency approvals or actions, if any; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2008.


SOURCE Watson Pharmaceuticals, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Watson Receives First FDA Approval for Manufacturing Product at Its Goa, India Facility
2. Watson Wyatt Identifies Major Benefit Trends During Open Enrollment Season
3. Texas Affiliates of Susan G. Komen for the Cure, Sen. Kirk Watson, Rep. Patrick Rose, Singer Kelly Willis, Breast Cancer Survivors and Activists Rally for Passage of Proposition 15
4. Watson Files FDA Application for Generic YAZ(R)
5. Watson Names Mark Durand Chief Financial Officer
6. Watson and Novartis Settle Lawsuit Over Exelon(R) Patent Litigation
7. Barr Subsidiary Sues Watson and Sandoz for SEASONALE(R) Patent Infringement
8. Watson Confirms Patent Litigation With Barr Related to Seasonale(R)
9. Watson Receives FDA Approval for Generic DuoNeb(R)
10. Watson to Distribute Alendronate Tablets
11. Medical Cost Increases to Accelerate Worldwide Over Next Five Years, Watson Wyatt Poll Finds
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... ... scholarships for people struggling with eating disorders as a result of the $20,000 ... annual event, held at Fox Run Golf Club in Eureka, will help individuals ...
(Date:11/25/2015)... ... 25, 2015 , ... "When I underwent breast reconstruction following ... uncomfortable," said an inventor from Bronx, N.Y. "In order to meet my own ... BRA for added comfort and support. The bra is easier to put on ...
(Date:11/25/2015)... ... , ... An unlikely combination of recycled plastic shopping bags ... people to have a more dignified and comfortable night’s sleep. , Residents of ... plastic bags into sleeping mats for the homeless. The project, according to ...
(Date:11/25/2015)... ... 25, 2015 , ... Bcureful—a non-profit organization devoted to advancing ... public awareness of the disorder while helping to bring expert medical care and ... bolster progress at the Tuberous Sclerosis Complex Center at Ann & Robert H. ...
(Date:11/25/2015)... ... , ... Students and parents have something to be thankful for this Thanksgiving ... awards. California Casualty is proud to support the contest designed to utilize ... driving, the number one killer of young drivers. , Almost 1,000 entries of ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
(Date:11/25/2015)... 2015 Allergan plc (NYSE: AGN ... Therapeutics, a start-up  biotechnology company focused on the ... and funded by the F-Prime Biomedical Research Initiative ... an exclusive collaboration to support the discovery and ... (ASD) and Obsessive Compulsive disorders (OCD). ...
(Date:11/25/2015)... Israel , November 25, 2015 ... "New Investors"), pursuant to which BioLight and the New ... IOPtima Ltd. subsidiary ("IOPtima") via a private placement. The ... of its innovative IOPtimate™ system used in the treatment ... approval pathway process for the IOPtimate™ system with the ...
Breaking Medicine Technology: