Navigation Links
ONSOLIS to Benefit from Approval of Class-Wide REMS for All Transmucosal Fentanyl Products
Date:12/29/2011

RALEIGH, N.C., Dec. 29, 2011 /PRNewswire/ -- BioDelivery Sciences International, Inc. (Nasdaq: BDSI) responded to the approval and announcement by the U.S. Food and Drug Administration (FDA) that a Risk Evaluation Mitigation Strategy (REMS) covering all transmucosal fentanyl products has been approved.  The program, which will be referred to as the Transmucosal Immediate Release Fentanyl (TIRF) REMS Access Program, was designed to ensure informed risk-benefit decisions before initiating treatment with a transmucosal fentanyl product, and while patients are on treatment, to ensure appropriate use.

(Logo: http://photos.prnewswire.com/prnh/20110217/CL49801LOGO)

The approved program covers all marketed transmucosal fentanyl products under a single program.  BDSI believes one single program will help to enhance patient safety while limiting the potential administrative burden on prescribers of transmucosal fentanyl products and their patients.  One common program also ends the disparity in prescribing requirements for ONSOLIS (fentanyl buccal soluble film), which is commercialized in the U.S. by Meda Pharmaceuticals, compared to other similar products.  The program was driven through a collaborative effort between companies with transmucosal fentanyl products, including our commercialization partner Meda Pharmaceuticals, and FDA.

"BDSI was the first company required by the FDA to have a REMS program for a transmucosal fentanyl product," stated Dr. Mark A. Sirgo, President and Chief Executive Officer of BDSI.  "Unfortunately, companies with similar products being marketed prior to the approval of ONSOLIS were not all held to the same standard.  This resulted in a significant commercial disadvantage for ONSOLIS given the requirements of the REMS and the associated additi
'/>"/>

SOURCE BioDelivery Sciences International, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related medicine technology :

1. BioDelivery Sciences Announces Commercial Launch of ONSOLIS in Canada
2. BioDelivery Sciences Provides Update on Status of Modified REMS Program for ONSOLIS
3. IQWIG Publishes Early Benefit Assessment for Pirfenidone
4. Texas to Modernize Medicaid Rx Benefits, Curb Pharmacy Overpayments
5. Bayers Drospirenone-containing Combination Oral Contraceptives: FDA Advisory Committees Affirm Positive Benefit-risk Profile and Recommend an Update of Labels to Reflect Information From Available Studies
6. Breast Cancer Vaccine Reduces Cancer Recurrence in Women: Interim Results From Phase 2 Clinical Trial Trend Toward AE37 Vaccine Benefit; Results Presented at SABCS
7. Survival Benefit With Syndax Pharmaceuticals Entinostat Maintained in Women with Advanced Breast Cancer
8. New Consumer Survey Finds Overwhelming Satisfaction with Pharmacy Benefits
9. Linking EudraCT and ClinicalTrials.gov Records Provides Huge Benefit
10. AMCP Urges HHS to Allow Flexibility in the Design of Prescription Drug Benefits Under Health Care Reform Law
11. Upgraded ACCF/ AHA/ SCAI Guidelines Reinforce Benefits of Volcanos Precision Guided Therapy Technologies
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/20/2014)... 2014   Ventana Medical Systems, Inc.  (Ventana), ... that its VENTANA System for Primary Diagnosis 1 ... Union for routine pathology, including primary diagnosis with ... Virtuoso software coupled with either the VENTANA iScan ... provides automated digital slide creation, case management and ...
(Date:8/20/2014)... 2014 ApolloDx™ today announced it will unveil ... special event at the company,s office in ... 2014. The event, which will start at 10:00 a.m., ... www.apollodx.com .    "We believe our mobile ... Bauer , Co-Founder and Managing Partner of ApolloDx. In ...
(Date:8/20/2014)... SAN DIEGO , Aug. 20, 2014 ... molecular diagnostics, announced today that results from two clinical ... (IPV) conference for the Company,s urine-based diagnostic test for ... (HPV). The IPV conference is scheduled to take place ... st to 25 th . Additionally, a new ...
Breaking Medicine Technology:Full digitization of the anatomic pathology lab is here with the VENTANA System for Primary Diagnosis 2Full digitization of the anatomic pathology lab is here with the VENTANA System for Primary Diagnosis 3Trovagene Provides Update on Its Urine-Based HPV Test 2Trovagene Provides Update on Its Urine-Based HPV Test 3
... 2007 /PRNewswire-USNewswire/ -- The,following statement may be attributed ... Medical Research (CAMR): , "In the face of ... the stroke of his veto pen deliberately to ... well as endanger,the future health and well being ...
... - Elixir,Pharmaceuticals, Inc., announced today the publication ... (mitiglinide calcium,hydrate) monotherapy, or combination therapy with ... meals. The data were,published in the Abstract ... Scientific Sessions in Chicago, Illinois.,Glufast is an ...
Cached Medicine Technology:President Bush Ignores America's Plea for Support of Stem Cell,Research 2Elixir Pharmaceuticals Announces Clinical Data at American Diabetes,Association Conference Highlighting Ability of Glufast to Maintain,Glycemic Control in Patients with Type 2 Diabetes 2Elixir Pharmaceuticals Announces Clinical Data at American Diabetes,Association Conference Highlighting Ability of Glufast to Maintain,Glycemic Control in Patients with Type 2 Diabetes 3Elixir Pharmaceuticals Announces Clinical Data at American Diabetes,Association Conference Highlighting Ability of Glufast to Maintain,Glycemic Control in Patients with Type 2 Diabetes 4Elixir Pharmaceuticals Announces Clinical Data at American Diabetes,Association Conference Highlighting Ability of Glufast to Maintain,Glycemic Control in Patients with Type 2 Diabetes 5
(Date:8/20/2014)... approach to treating cancer - using Botox. A study ... Translational Medicine shows that cancer growth could be ... are linked to cancer stem cells. The approach thus ... treatment cheap, safe and efficient. The researchers have thus ... start testing on humans. , The nervous system is ...
(Date:8/20/2014)... August 20, 2014 Quincy Bioscience, a ... 500|5000 list of the fastest growing private companies ... Ranking at No. 2,941, Quincy Bioscience is honored again ... the United States. , Quincy Bioscience is manufacturer of ... – a protein originally discovered in jellyfish and clinically ...
(Date:8/20/2014)... DALLAS (PRWEB) August 20, 2014 Caddis ... track records of any healthcare real estate company in ... of medical assets valued at $500 million, including more ... of that significant growth, including expansions into new geographic ... expanded capabilities, company executives are pleased to announce an ...
(Date:8/20/2014)... Beach, Florida (PRWEB) August 20, 2014 ... Florida, with the help of their experienced surgeons trained ... of patients to regain their lost or inaccurate vision. ... for performing Lasik surgery is making it possible for ... aging disease which occurs normally in people in the ...
(Date:8/20/2014)... Antonio, TX (PRWEB) August 20, 2014 Texas ... their new study. The study will help test the effectiveness ... who suffer from high cholesterol may be eligible to participate ... too much cholesterol in the blood can lead to cardiovascular ... States. Lowering cholesterol can help reduce the risk of heart ...
Breaking Medicine News(10 mins):Health News:Treating gastric cancer -- with Botox 2Health News:Quincy Bioscience Recognized in Inc. 500|5000 List of America’s Fastest Growing Companies for Third Consecutive Year 2Health News:Caddis Rebrands to Emphasize Its Growth, Expanded Capabilities 2Health News:Caddis Rebrands to Emphasize Its Growth, Expanded Capabilities 3Health News:Caddis Rebrands to Emphasize Its Growth, Expanded Capabilities 4Health News:Braverman Eye Center Now Offers Multifocal PresbyLasik in Florida by Trained Surgeons 2Health News:Texas Medical Research Associates Announce New Study 2
... Income in Company History, BELLEVUE, Wash., Feb. 6 ... provider of health, beauty, vision, and,pharmacy products, today announced ... ended December 30, 2007. The company reported,quarterly net sales ... $0.00,per share. The company achieved record gross margins in ...
... of Mobility Program Helps Eden Home Resident regain mobility and,Be ... is a "sweetheart with a sweet tooth" say his friends ... a borrowed power wheelchair,from delivering mail at the facility where ... self-professed "chocoholic." To keep him on the,go, The SCOOTER Store ...
... 6 The Juvenile,Products Manufacturers Association (JPMA), which ... United States, stands by the,scientific research indicating that ... to fall victim to scare tactics., There ... Bisphenol-A, a,material used to make tough, shatter-resistant polycarbonate ...
... Va., Feb. 6 The HealthCentral,Network, Inc. ... accomplished dermatologist, cosmetic surgeon and author, is,joining the ... Sundaram is the author of Face Value: The ... It [Rodale], which was honored by,the National Press ...
... Medical,Innovations, Inc. (Amex: IMA ), a leading ... consumer and professional markets, announced,today that it will ... being held February 11 through 13, 2008 at ... Zwanziger, Chief Executive Officer, and Jon Russell,Vice President, ...
... saves lives. It saves money. And it,s time., ... of the,growing momentum for electronic prescribing (e-prescribing), Health ... before the,Senate Finance Committee that e-prescribing standards and ... adopt the technology in Medicare., When questioned ...
Cached Medicine News:Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 2Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 3Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 4Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 5Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 6Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 7Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 8Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 9Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 10Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 11Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 12Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 13Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 14Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 15Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 16Health News:drugstore.com inc. Achieves GAAP Profitability in the Fourth Quarter of 2007 17Health News:The SCOOTER Store Donates Power Wheelchair to New Braunfels Car Crash Victim 2Health News:JPMA on the Safety of Baby Bottles 2Health News:Prominent Cosmetic Dermatologist and Author Joins MySkinCareConnection.com 2Health News:Prominent Cosmetic Dermatologist and Author Joins MySkinCareConnection.com 3Health News:Inverness Medical Innovations to Present at 2008 UBS Global Healthcare Services Conference on February 13, 2008 2Health News:PCMA Applauds Secretary Leavitt's Support for Requiring E-Prescribing in Medicare 2Health News:PCMA Applauds Secretary Leavitt's Support for Requiring E-Prescribing in Medicare 3
20L...
... new Finnpipette Focus from Thermo ... combine ergonomics with uncompromising performance. ... plate offers a custom fit ... new shorter tip cones allow ...
... fixed pipette is ideal for ... volume. Fixed volume FInnpipettes offer ... as other Finnpipette Digital pipettes: ... blow-out (1-40ul), Soft-touch tip ejection, ...
... includes fixed-volume, adjustable-volume, and multichannel models ... Research pro Pipette. Designed with a ... pipettes have earned a worldwide reputation ... with original Eppendorf pipette tips, they ...
Medicine Products: