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:3/29/2017)... , ... March 29, 2017 , ... During the last ... provide free screening colonoscopies to eligible individuals in the local community. , Colon ... but regular screenings can detect colon cancer while it is small, confined and easier ...
(Date:3/29/2017)... , ... March 29, 2017 , ... Full Contact K9, ... of Pet Protect Law that assists dog owners in creating legally-enforceable pet ... owners in taking the natural next step to protect their new companion. Says Evan ...
(Date:3/29/2017)... Petersburg, FL (PRWEB) , ... March 30, 2017 , ... ... called the "Spice of Life" or "Wonder Spice", it has been used for thousands ... use in the East," says Heshelow, author of " Turmeric: How to Use it ...
(Date:3/29/2017)... ... March 29, 2017 , ... The Wall Centre Dental ... new patients from Burnaby, BC. Patients in need of experienced orthodontics, laser dentistry, ... see the esteemed team at Wall Centre Dental. Drs. Parviz Roshan, Siamak Tehrani, ...
(Date:3/29/2017)... ... March 29, 2017 , ... ... as it continues developing an ANSI-approved, consensus-based American National Standard for Good ... to publish the first ANSI-approved GMP standard for dietary supplements this spring, ...
Breaking Medicine News(10 mins):
(Date:3/29/2017)... , March 29, 2017  The Global ... Japanese public-private partnership formed to battle infectious diseases ... totaling US$23 million* that could help deliver a ... of debilitating conditions. This latest ... Phase 3 clinical trial testing a pediatric formulation ...
(Date:3/29/2017)... TREE, Colo. , March 29, 2017  Zynex (OTCQB: ... manufacture and sale of non-invasive medical devices for pain ... today that it will host the Company,s 2016 full-year ... a.m. Eastern Time.) The Company expects to ... 31, 2017. ...
(Date:3/29/2017)... 29, 2017  Glenmark Pharmaceuticals, a global pharmaceutical ... an investigational fixed-dose combination of mometasone furoate (25 ... as a nasal spray being studied for the ... from a recently completed Phase 3 trial assessing ... therapy versus mometasone, olopatadine or placebo. ...
Breaking Medicine Technology: