Navigation Links
Labopharm's response for novel trazodone formulation accepted by FDA as complete - Designated as Class 2 resubmission

- 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

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:
(Date:11/27/2015)... CA (PRWEB) , ... November 27, 2015 , ... ... use in Final Cut Pro X. With ProSidebar: Fasion, video editors can easily ... use ProSidebar as a minimalist title opener. Utilize presets featuring self-animating drop zones, ...
(Date:11/27/2015)... ... November 27, 2015 , ... The ... prided itself for not only fulfilling the needs of advisers and clients but ... affordable price and providing top-tier customer service. However, there's always room for improvement, ...
(Date:11/27/2015)... ... 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces his ... is one of Joplin's most famous and beautiful concert posters. The concert was held ... Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's stardom ...
(Date:11/26/2015)... (PRWEB) , ... November 26, 2015 , ... ... American Express Travel Representative. As a franchise owner, Somu now offers travelers, value ... cruise, destination wedding packages, private cruise sales, as well as, cabin upgrades and ...
(Date:11/26/2015)... ... November 26, 2015 , ... Pixel Film Studios brings ... with ProTrailer: Vintage. This newly styled ProTrailer pack comes with 30 all-new vintage-inspired ... font, giving users limitless opportunities to stylize and create designs quickly and easily, ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... , Nov. 26, 2015  The total global healthcare ... 7% over 2015-2016. Latin America has ... , (excluding Japan ), is second ... continues to face increased healthcare expenditure. In 2013-2014, total ... declined from 43.5% in 2008-2009 to 41.2% in 2013-2014. In ...
(Date:11/25/2015)... 2015 AAIPharma Services Corp./Cambridge Major Laboratories, ... least $15.8  Million to expand its laboratories and ... . The expansion will provide additional office space ... demands of the pharmaceutical and biotechnology markets. ... provide up to 40,000 square feet of expanded ...
(Date:11/25/2015)... Israel , November 25, 2015 ... KTOV ) (TASE: KTOV), a biopharmaceutical company focused ... treatment of various clinical conditions, today announced the closing ... American Depository Shares ( ADSs ), each representing 20 ... up to 3,158,900 ADSs. The ADSs and warrants were ...
Breaking Medicine Technology: