Navigation Links
FDA Approves Shared REMS (Risk Evaluation and Mitigation Strategy) Program for all TIRF (Transmucosal Immediate Release Fentanyl) Pain Treatments
Date:12/30/2011

in any of the individual REMS programs will be automatically enrolled in the shared system in March 2012.

"ProStrakan is thrilled to see our hard work and the work of the industry working group culminate in this approval," said Anthony G. Oladipo, Pharm.D., M.P.H, BCPS, VP Global Head of Drug Safety & Risk Management, ProStrakan, Inc. "We are fully committed to patient safety and pleased to help the FDA achieve its goal of assuring appropriate use of pain medications."

ProStrakan's product, ABSTRAL is the first and only rapidly-disintegrating tablet placed under the tongue for breakthrough cancer pain. In January 7, 2011 it was approved by the FDA for use in cancer patients, 18 years of age or older, who are already receiving, and who are tolerant to, opioid therapy for their underlying persistent cancer pain.

"ABSTRAL provides a simple, patient-friendly and efficacious treatment option for cancer patients with breakthrough pain, which can be incapacitating, limiting patients' ability to participate in daily activities," said John Higgins, General Manager, ProStrakan, Inc. "Now, all TIRF products will be administered equally through a single REMS, making the process simpler for prescribers, patients, pharmacists, and distributors."

Breakthrough cancer pain, common in up to two-thirds of people with cancer-related pain, affects a patient's quality of life, including physical and emotional health, interpersonal relationships and the ability to engage in certain activities. Breakthrough pain (BTP) is described as severe pain that "breaks through" the patient's round-the-clock pain medicine.[i] Opioids are among the most potent and effective analgesics, or medicines given to reduce pain, but unfortunately are also some of the most misused and abused medicines.

For more information on ABSTRAL, please visit www.ABSTRAL.com. For more information on the TIRF REMS Access program, please visit '/>"/>

SOURCE ProStrakan, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Page: 1 2 3 4 5 6

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/29/2015)... 30, 2015 Roche (SIX: RO, ROG; OTCQX: ... EGFR Mutation Test v2 for Premarket Approval (PMA) ... as a companion diagnostic test for AZD9291, an ... patients with an acquired resistant mutation.  ... have adenocarcinoma with tumor containing an EGFR sensitizing ...
(Date:7/29/2015)... Calif. , July 29, 2015  UBM Canon ... San Diego Marriott Marquis & Marina on September 1-2, ... device industry. A highlight of the Business Development track ... Backing from Different Types of Investors, featuring Renee ... Johnson Development Corporation; Brent Ahrens , Partner, Canaan ...
(Date:7/29/2015)... Calif. and CAMBRIDGE, Mass. ... Inc. (NASDAQ: ISIS ), the leader in ... subsidiary, announced today that The New England ... a Phase 2 clinical study evaluating volanesorsen (formerly ... to severely high triglycerides. This publication follows the ...
Breaking Medicine Technology:Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy 2Roche submits filing to FDA for companion diagnostic for non-small cell lung cancer drug therapy 3MEDevice San Diego Offers Tips on Securing Financial Backing from Investors 2Positive Clinical Data From Volanesorsen Published in the New England Journal of Medicine 2Positive Clinical Data From Volanesorsen Published in the New England Journal of Medicine 3Positive Clinical Data From Volanesorsen Published in the New England Journal of Medicine 4Positive Clinical Data From Volanesorsen Published in the New England Journal of Medicine 5Positive Clinical Data From Volanesorsen Published in the New England Journal of Medicine 6Positive Clinical Data From Volanesorsen Published in the New England Journal of Medicine 7
... Aug. 24 Physicians at Southern,Health have started a ... a new strategy for defeating hepatitis C viral infection, ... Implicit Bioscience,s drug, oglufanide disodium, which works as ... by intranasal,administration to patients with chronic hepatitis C viral ...
... Fund Continued Rapid Growth and Innovation, AUDUBON, Pa., ... implant manufacturer in the world, today announced,the closing of ... led the round and was joined by AIG SunAmerica ... Securities, LLC acted,as sole placement agent. The Series ...
Cached Medicine Technology:Drug in New Hepatitis C Clinical Trial 2Globus Medical Raises $110 Million in Series E Financing Round 2
(Date:7/30/2015)... ... 2015 , ... Boston Web Marketing is proud ... Partners is the platform for search marketing agencies to communicate with the Google ... to run successful search marketing campaigns. Google Partners also affords businesses the opportunity ...
(Date:7/30/2015)... CA (PRWEB) , ... July 30, 2015 , ... Ocean ... honors available, including the very rare “no recommendations.” No recommendations means CARF found no ... this is a notation that less than 3% of all facilities receive. In addition, ...
(Date:7/30/2015)... ... July 30, 2015 , ... The ... Cancer Institute Designation , The Tisch Cancer Institute (TCI) at the Icahn School ... cancer center. TCI joins an elite group of 69 cancer institutions nationwide that ...
(Date:7/30/2015)... (PRWEB) , ... July 30, 2015 , ... 1Heart Caregiver ... 2015 - “Learn How to Make Money in the Booming Homecare Business.” This will ... CA 90010. , The event will be hosted by 1Heart’s very ...
(Date:7/30/2015)... ... July 30, 2015 , ... Summer is the dry eye ... to that a particularly long, dry and hot 2015 summer season and the dry ... water advocate Sharon Kleyne will discuss the 2015 summer season and identify the primary ...
Breaking Medicine News(10 mins):Health News:Boston Web Marketing Attends Google Partners All-Stars Summit 2Health News:Ocean Hills Recovery Receives Accreditation from CARF International 2Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 2Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 3Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 4Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 5Health News:The Tisch Cancer Institute at Icahn School of Medicine at Mount Sinai Earns National Cancer Institute Designation 6Health News:Upcoming Business Seminar at 1Heart Caregiver Services Headquarters Los Angeles California 2Health News:Fresh Water Advocate Sharon Kleyne Warns to Be Extra Cautious About Dry Eye “Hot Spot” Cities In Hot Dry Summer of 2015 2Health News:Fresh Water Advocate Sharon Kleyne Warns to Be Extra Cautious About Dry Eye “Hot Spot” Cities In Hot Dry Summer of 2015 3
... of scientists and health professionals from the field of ... the American Association of Physicists in Medicine (AAPM) from ... will present the latest technological advances in medical imaging ... issues facing the field today. AAPM is ...
... ... SDI study. Novo Nordisk increased sales calls to endocrinologists 30%. , ... (Vocus) July 7, 2010 -- According to ... top company overall. The company was mentioned by 62% of the endocrinologists who participated ...
... , ... System in Louisiana is connecting thousands of physicians in the broader community to patient ... can now provide community and referring physicians across the region with access to information ... ...
... ... of the Health Literacy Advisor (HLA), the nation,s first interactive health literacy software tool, ... award innovators in health literacy., , ... (PRWEB) July 7, 2010 -- Health Literacy Innovations (HLI), ...
... IVR ... include SMS / Text Messaging. , ... Buffalo, NY (Vocus) July 7, 2010 -- IVR Technology Group (ITG) is pleased to ... . With this new addition to their product line up, they have now expand ...
... Jackson ... 35 years experience, has joined the executive team as Medical Director. , ... Alpharetta, GA (July 6, 2010) – Jackson Surgical ... years experience, has joined the executive team as Medical Director. Dr. Funk will be ...
Cached Medicine News:Health News:SDI Reports: Novo Nordisk Takes Top Ranking Among Endocrinologists, According To Pharmaceutical Company Image Study 2Health News:Ochsner Health System Connects Community Physicians to Electronic Medical Records; Orion Health HIE Solution Provides Access to Healthcare Providers Across the Gulf South 2Health News:Ochsner Health System Connects Community Physicians to Electronic Medical Records; Orion Health HIE Solution Provides Access to Healthcare Providers Across the Gulf South 3Health News:Ochsner Health System Connects Community Physicians to Electronic Medical Records; Orion Health HIE Solution Provides Access to Healthcare Providers Across the Gulf South 4Health News:Ochsner Health System Connects Community Physicians to Electronic Medical Records; Orion Health HIE Solution Provides Access to Healthcare Providers Across the Gulf South 5Health News:Health Literacy Innovations Announces 1st Annual Health Literacy Innovator Award — Anonymous Donor Offers Prize Money To Winners 2Health News:Health Literacy Innovations Announces 1st Annual Health Literacy Innovator Award — Anonymous Donor Offers Prize Money To Winners 3Health News:IVR Technology Group Announces MobileMarketing123.com 2Health News:Jackson Surgical Assistants Names Dr. Sidney Funk as Medical Director 2
The 81130 Xenon AC/DC light source is the brightest, smallest transportable unit avaliable. The quck charge rechargable battery and low power consumption allows for 2 hours continuous use in the fie...
Tested by surgeons for functionality and ergonomy. Uses the Medifix C1301-1CCD camera head....
Integrated electronics, single-chip CCD camera with PAL and NTSC output. PAL output at 460 lines, NTSC output at 470 lines, focal length 30mm. 90mm length x 20mm diameter....
Large image and wide-angle design....
Medicine Products: