Navigation Links
Labopharm's response for novel trazodone formulation accepted by FDA as complete - Designated as Class 2 resubmission
Date:8/25/2009

- New PDUFA action date assigned -

LAVAL, QC, Aug. 25 /PRNewswire-FirstCall/ - Labopharm Inc. (TSX: DDS; NASDAQ: DDSS) today announced the U.S. Food and Drug Administration (FDA) has accepted Labopharm's response regarding its novel formulation of the antidepressant trazodone as complete and designated it as a Class 2 resubmission. The FDA has assigned Labopharm a new Prescription Drug User Fee Act (PDUFA) action date of February 11, 2010.

Labopharm received a complete response letter from the FDA on July 17, 2009 indicating the Company's new drug application (NDA) for its novel trazodone formulation could not be approved in its present form due to deficiencies following the FDA's inspection of the manufacturing facility of the active pharmaceutical ingredient (API) supplier, Angelini. The letter did not raise any efficacy or safety issues. Angelini submitted an action plan addressing the deficiencies to the FDA on July 24, 2009.

Labopharm continues to prepare for the commercialization of its novel antidepressant and, pending FDA approval, intends to launch in the U.S. shortly thereafter.

About Labopharm Inc.

Labopharm is an emerging leader in optimizing the performance of existing small molecule drugs using its proprietary controlled-release technologies. The Company's lead product, a unique once-daily formulation of tramadol, is now available in 17 countries around the world, including the U.S., Canada, major European markets and Australia. The Company's second product, a novel formulation of trazodone for the treatment of major depressive disorder, is under regulatory review in the U.S. by the FDA. The Company also has a robust pipeline of follow-on products in both pre-clinical and clinical development. Labopharm's vision is to become an integrated, international, specialty pharmaceutical company with the capability to internally develop and commercialize its own products. For more information, please visit www.labopharm.com.

This press release contains forward-looking statements, which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including the uncertainties related to the regulatory process in various countries for the approval of the Company's products and the successful commercialization of the products throughout the world if they are approved. Investors should consult the Company's ongoing quarterly filings and annual reports for additional information on risks and uncertainties relating to these forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. The Company disclaims any obligation to update these forward-looking statements.


'/>"/>
SOURCE Labopharm Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Tumors use enzyme to recruit regulatory T-cells and suppress immune response
2. Study identifies key player in the bodys immune response to chronic stress
3. Retired NYPD Lieutenants William E. Keegan, Jr., Owen McCaffery and John Moran and Tom Thees, a former COO in the financial industry, announce today the formation of H.E.A.R.T (Healing Emergency Aid Response Team) 911.
4. Response Biomedical appoints S. Wayne Kay Chief Executive Officer
5. Merck & Co., Inc. Response to Todays New York Medicaid Suit
6. Maternal depression and controlling behavior associated with increased stress response in infants
7. Family history of alcoholism affects response to drug used to treat heavy drinking
8. Molecular fingerprint of breast-cancer drug resistance can predict response to treatment
9. Breast cancer susceptibility gene predicts outcome and response to treatment in lung cancer
10. PET scans can accurately detect a breast tumors response to chemotherapy
11. DNA damage response confers a barrier for viral tumorigenesis
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, the leading ... with Tennessee Counseling Association. This new relationship allows TherapySites to continue ... Association, adding exclusive benefits and promotional offers. , "TCA is extremely excited about ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, ... the 2016 Cereal Festival and World’s Longest Breakfast Table in Battle Creek, MI, where ... city’s history as home to some of the world’s leading providers of cereal and ...
(Date:6/25/2016)... ... June 25, 2016 , ... Experts from the American ... Annual Research Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. ... including advance care planning, healthcare costs and patient and family engagement. , AIR ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/24/2016)... ... 24, 2016 , ... Those who have experienced traumatic events may suffer from ... avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid this ... coping following a traumatic event. , Trauma sufferers tend to feel a range of ...
Breaking Medicine News(10 mins):
(Date:6/23/2016)... , , , WHEN: ... , , , , LOCATION: , , , Online, with ... , EXPERT PANELISTS:  , , , Frost & Sullivan,s Global Vice ... Senior Industry Analyst, Divyaa Ravishankar and Unmesh Lal, Program Manager , ... industry is witnessing an exceptional era. Several new demand spaces, such ...
(Date:6/23/2016)... , June 23, 2016 ... Oticon , industry leaders in advanced ... launch of Oticon Opn ™, the world,s first ... of possibilities for IoT devices.      (Photo: ... Oticon introduces a number of ,world firsts,: ...
(Date:6/23/2016)... 23, 2016 Research and Markets ... Volumes: Global Analysis (United States, China, Japan, Brazil, United ... to their offering. ... healthcare business planners, provides surgical procedure volume data in ... with an in-depth analysis of growth drivers and inhibitors, ...
Breaking Medicine Technology: