Navigation Links
FDA Clears the Way for Generic Versions of Transdermal Patches to Treat Chronic Pain

The Food and Drug Administration (FDA) has granted approval to Mylan Technologies, Inc., for the first generic version of Alza Corporation's Duragesic Patch (Fentanyl Transdermal System) used to treat patients suffering from severe chronic pain that cannot be managed with alternative analgesics. When applied to the skin, this patch technology delivers fentanyl, an opioid pain medication that is slowly absorbed into the body through the skin providing pain relief for up to three days (72 hours).

The agency's approval is expected to provide patients with access to a lower cost alternative of this pain management system. At the same time that FDA approved Mylan's generic product, it acted on several citizens' petitions requesting that FDA deny or delay approval of the product.

The original Fentanyl Transdermal System was approved in August 1990. It is currently approved for the management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be managed by acetaminophen-opioid combinations, non-steroidal analgesics, or as needed dosing with short-acting opioids.

Fentanyl is currently a Schedule II controlled substance, which is the highest level of control for drugs with a recognized medical use. As a controlled substance in Schedule II of the Controlled Substances Act (CSA), Fentanyl also comes under the jurisdiction of the Drug Enforcement Administration (DEA), which administers the CSA. Schedule II drugs are subject to manufacturing quotas set by DEA with input on medical need from FDA, distribution tracking, import and export controls, registration of prescribers and dispensers, and written prescriptions without refills.


'"/>

Source:FDA


Page: 1

Related biology news :

1. Prescription Drug Patches Gaining Ground, Tackling New Therapies
2. Discovery Could Lead To Novel Approaches In HIV Treatment
3. New Treatment Rivals Chemotherapy For Lymphoma, Study Finds
4. FDA Approves New Drug to Treat Type I and Type II Diabetes
5. Rush Physicians Using Gene Therapy For Heart Patients With Moderate To Severe Chest Pains Who Do Not Benefit From Other Treatments
6. Ophthalmologists Use Artificial Silicon Retina Microchip To Treat Vision Loss
7. Effective Cancer Treatments Follow The Clock
8. Potential Drug Target For Treating Cocaine Abuse Found
9. Protein Discovery Could Unlock The Secret To Better TB Treatment
10. Embryonic Stem Cells Treated With Growth Factor Reverse Hemophilia In Mice: UNC Researchers
11. Natural Killers Could Lead to New Hepatitis Treatments
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/30/2017)... -- On April 6-7, 2017, Sequencing.com will host the world,s ... at Microsoft,s headquarters in Redmond, Washington ... health and wellness apps that provide a unique, personalized ... is the first hackathon for personal genomics and the ... the genomics, tech and health industries are sending teams ...
(Date:3/29/2017)... 2017  higi, the health IT company that operates ... America , today announced a Series B investment ... EveryMove. The new investment and acquisition accelerates higi,s strategy ... transform population health activities through the collection and workflow ... higi collects and secures data today on behalf of ...
(Date:3/24/2017)... MILAN , March 24, 2017 The Controller ... Deputy Controller Mr. Abdulla Algeen have received the prestigious international ... Continue Reading ... ... small picture) and Deputy Controller Abdulla Algeen (small picture on the right) ...
Breaking Biology News(10 mins):
(Date:5/19/2017)... ... 19, 2017 , ... The University City Science Center is ... for commercialization, and who are affiliated with the 21 partner academic and research ... now in its tenth round, is the first multi-institutional proof-of-concept program for the ...
(Date:5/18/2017)... ... 16, 2017 , ... Clinical Supplies Management (“CSM”), a Great Point Partners II ... grow. CSM has doubled in size over the past six months with the ... , Roger Gasper joins CSM as Chief Financial Officer. Roger has over 25 ...
(Date:5/18/2017)... ... May 17, 2017 , ... Cognition Corporation ... commercialization, has just released version 9.0 of the Cognition Cockpit platform. , “Our ... Cockpit,” says David Cronin, CEO of Cognition. “We’re thrilled to finally be able ...
(Date:5/18/2017)... ... 17, 2017 , ... G-CON Manufacturing, Inc., the leader in ... Jornitz, was recognized as a Top 10 Industry Influencer on The Medicine Maker’s ... bettering the pharma industry and bringing life-changing medicines to market” across four categories. ...
Breaking Biology Technology: