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, spe
'/>"/>

SOURCE Labopharm Inc.
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2

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:8/21/2014)... BambooIndustry.com is an internationally well-known supplier ... recently unveiled its new collection of elegant bamboo ... customers who are looking for high quality floorings for ... with great savings (up to 29 percent off). Before ... cheap products. , The company’s bamboo flooring products ...
(Date:8/21/2014)... Ann Arbor, Mich. Using heart-lung support technology, the ... the number of kidneys, livers and pancreases available for ... published in the journal Transplantation and detail ... Extracorporeal Membrane Oxygenation, or ECMO, to improve the quality ... death. , "Organ transplant is limited by the number ...
(Date:8/21/2014)... Dallas, TX (PRWEB) August 21, 2014 ... August 20 entertained residents with dementia at Silverado Turtle ... Improv Troupe, which consists of entertainers ranging from ages ... each time they perform their 40-minute set. The troupe's ... makes it universal and allows them to touch audiences ...
(Date:8/21/2014)... (HealthDay News) -- Black mothers are less likely than ... possible reason why: Hospitals in neighborhoods with many black ... areas with more white residents, a U.S. government study ... less common in medical centers where the black population ... for Disease Control and Prevention reported Thursday. These ...
(Date:8/21/2014)... (PRWEB) August 21, 2014 The ... 10th anniversary and a national voice in the ... in health disparities during the 112th National Medical ... Distinguished honorees included: , John Ruffin, Ph.D, former ... and Health Disparities, whose life-long career and innovations ...
Breaking Medicine News(10 mins):Health News:Buy Elegant Bamboo Floorings from Internationally Well-known Supplier BambooIndustry.com 2Health News:Extracorporeal support can significantly increase number of organs for transplant 2Health News:Unicorn Clearance Improv Troupe Brings Laughter to Residents with Dementia at Silverado Memory Care 2Health News:Racial Disparities in Breast-Feeding May Start With Hospitals, Study Suggests 2Health News:W. Montague Cobb/NMA Health Institute Honors Three Outstanding Leaders in Health Disparities 2
... METAIRIE, La., June 3 OrthoSynetics(TM), the largest,provider ... has added two new members to its IT ... software developer and David D,Entremont has,been hired as ... strengthen every facet of our organization, and,the addition ...
... costs, DETROIT, June 3 Blue Cross Blue ... group efforts to become,patient-centered medical homes, a concept that ... companies are sponsoring a forum at,1:30 p.m. on Wednesday, ... Grand River Avenue in New Hudson., "We want ...
... faces radiation, chemotherapy treatments for what doctors say ... 3 (HealthDay News) -- Sen. Edward M. Kennedy ... the hallways of Duke University Medical Center on ... called a "successful" three-and-a-half-hour surgery to treat his ...
... Scientists at Cold Spring Harbor Laboratory (CSHL) have taken ... In a newly published paper, they confirm that a ... demonstrated in living mice that its deletion, inactivation or ... liver cancer closely related to common human epithelial cancers ...
... B. Snow,Jr., chairman & chief executive officer, Medco Health ... the Goldman Sachs Twenty-Ninth Annual,Global Healthcare Conference on June ... Laguna Niguel, CA, will begin at,1:20 p.m. PT (4:20 ... scheduled to attend., The presentation may be heard ...
... minor surgery reveals inoperable pancreatic and spinal cancer, ... had finally settled into a quiet life at Avamere ... at his,paintings and frequent visits from his daughter Yolanda ... in years past -- leading,chartered cruises in the Caribbean ...
Cached Medicine News:Health News:OrthoSynetics(TM) Adds Two Experienced Pros to IT Team 2Health News:Blue Cross Blue Shield of Michigan Forum Examines Cutting-Edge Medical Care That Better Meets Patients' Needs 2Health News:Blue Cross Blue Shield of Michigan Forum Examines Cutting-Edge Medical Care That Better Meets Patients' Needs 3Health News:Sen. Kennedy Up and Walking After Brain Tumor Surgery 2Health News:Sen. Kennedy Up and Walking After Brain Tumor Surgery 3Health News:Sen. Kennedy Up and Walking After Brain Tumor Surgery 4Health News:CSHL scientists trace causal link between a tumor suppressor gene and liver cancer 2Health News:CSHL scientists trace causal link between a tumor suppressor gene and liver cancer 3Health News:Medco CEO to Present at the Goldman Sachs Twenty-Ninth Annual Global Healthcare Conference 2Health News:Sherwood, Oregon Sailor, 78, Goes on Final Voyage 2
(Date:8/21/2014)... Eisai Limited is pleased to support the Canadian Epilepsy Alliance ... in Canada . The comic book, an ... and their parents about epilepsy, the most common neurological disorder ... Canadians. Eisai is guided by a corporate philosophy known as ... is central – there was a need within the epilepsy ...
(Date:8/21/2014)... Kan. , Aug. 21, 2014 /PRNewswire-iReach/ -- ... Trust Alliance (HITRUST) under its Common Security Framework ... Enterprise Security and Privacy Manager, "We appreciate this ... level of commitment that this certification signifies. Our ... ABOUT THE CSF CERTIFICATION PROCESS: ScriptPro,s ...
(Date:8/21/2014)... N.Y. , Aug. 21, 2014  Henry Schein, Inc. ... health care products and services to office-based dental, animal health ... at two investor conferences in September: , September ... New York , NY at 12:50 p.m. ET , ... Conference in New York , NY at 1:25 ...
Breaking Medicine Technology:Eisai Pleased to Support Canadian Epilepsy Alliance Comic Book that Teaches Children About Epilepsy 2ScriptPro Achieves HITRUST Certification 2Henry Schein To Present At Two Investor Conferences In September 2
Tongs...
Bipolar forceps...
... Noise Reduction (ANR)technology, internal to the ... of distracting room,noise, greatly enhancing overall ... different from electronic filtering, which may ... body sounds clinicians need to hear.,Because ...
... INFORM HPV allows the pathologist to visualize ... HPV allows testing on a choice of sample ... ,INFORM HPV cocktails utilize proprietary probe formulations. The ... HPV genotypes 16, 18, 31, 33, 35, 39, ...
Medicine Products: