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:5/24/2017)... ... 24, 2017 , ... Accordant Technology, a trusted IT solutions ... an analytics-first approach, layered with machine learning, that provides real-time visibility into the ... cloud to the edge. Through the new partnership, customers get the real-time situational ...
(Date:5/24/2017)... ... ... Lowe is a sought after actor, and also serves as the host of the ... all aspects of life, and a new segment is being developed on podiatry, which ... is essential to people’s overall well-being, and if viewers have feet problems, they may ...
(Date:5/24/2017)... ... , ... Technique, technique, technique – with a dash of common sense. Those ... and exercise or simply lifting heavy objects, advises Dr. Kaliq Chang, interventional pain management ... says. “Improper technique in lifting anything heavy or an attempt to lift too much ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... Axiad ... organizations, today announced CIO Applications magazine has named the company a “Top 25 ... use of the Cloud to help organizations simply and proactively address potential cybersecurity threats ...
(Date:5/23/2017)... ... May 23, 2017 , ... Cambridge, MA, May ... since 2009, according to a Workers Compensation Research Institute (WCRI) study, a contrast ... North Carolina System: CompScope™ Benchmarks, 17th Edition looks at indemnity and medical ...
Breaking Medicine News(10 mins):
(Date:5/4/2017)... Israel , May 4, 2017  DarioHealth Corp. ... mobile health and big data solutions, today announced that ... A&D Company, and STI Technologies Limited to lower diabetes ... immediately. Through STI,s innoviCares card, which is available throughout ... , DarioHealth customers will be eligible for additional savings ...
(Date:5/3/2017)... May 3, 2017  Kalorama Information notes that ... percent next year and this is projected to ... stem cell (HSCT) or bone marrow transplants require ... are well-suited for this task. This according to ... Kalorama Information. The various PCR-based methodologies, Sanger sequencing ...
(Date:5/2/2017)... , May 2, 2017  George Clinical, a ... region, and Vector Oncology, a ... and data analytics, formally announced today that George Clinical ... the transaction has the dual purpose of strengthening ... led oncology trial delivery solutions throughout the ...
Breaking Medicine Technology: