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.



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:

(Date:5/16/2016)... , May 16, 2016   EyeLock LLC ... today announced the opening of an IoT Center of ... strengthen and expand the development of embedded iris biometric ... unprecedented level of convenience and security with unmatched biometric ... one,s identity aside from DNA. EyeLock,s platform uses video ...
(Date:5/9/2016)... 9, 2016 Elevay is currently ... expanding freedom for high net worth professionals seeking travel ... globally connected world, there is still no substitute for ... duplicate sealing your deal with a firm handshake. This ... taking advantage of citizenship via investment programs like those ...
(Date:4/28/2016)... , April 28, 2016 Infosys ... (NYSE: INFY ), and Samsung SDS, a global ... that will provide end customers with a more secure, fast ...      (Logo: ) , ... but it also plays a fundamental part in enabling and ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... 27, 2016 , ... Parallel 6 , the leading software as a ... Reach Virtual Patient Encounter CONSULT module which enables both audio and video telemedicine ... team. , Using the CONSULT module, patients and physicians can schedule a face to ...
(Date:6/24/2016)... 2016  Regular discussions on a range of subjects including ... two entities said Poloz. Speaking at a lecture ... , he pointed to the country,s inflation target, which is ... "In certain areas there ... common economic goals, why not sit down and address strategy ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... announce the launch of their brand, UP4™ Probiotics, into Target stores nationwide. The ... is proud to add Target to its list of well-respected retailers. This list ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm Sciences, Inc. is ... has received AOAC Research Institute approval 061601. , “This is another AOAC-RI approval ... Bob Salter, Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods ...
Breaking Biology Technology: