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:4/15/2016)... , April 15, 2016  A new ... make more accurate underwriting decisions in a fraction ... timely, competitively priced and high-value life insurance policies ... screenings. With Force Diagnostics, rapid testing ... lifestyle data readings (blood pressure, weight, pulse, BMI, ...
(Date:4/13/2016)... CHICAGO , April 13, 2016  IMPOWER physicians ... are setting a new clinical standard in telehealth ... By leveraging the higi platform, IMPOWER patients can ... weight, pulse and body mass index, and, when they ... quick and convenient visit to a local retail location ...
(Date:3/29/2016)... 2016 LegacyXChange, Inc. (OTC: ... SelectaDNA/CSI Protect are pleased to announce our successful effort ... variety of writing instruments, ensuring athletes signatures against counterfeiting ... from athletes on LegacyXChange will be assured of ongoing ... Bill Bollander , CEO states, "By ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... 23, 2016  The Biodesign Challenge (BDC), a university ... to harness living systems and biotechnology, announced its winning ... New York City . ... showcased projects at MoMA,s Celeste Bartos Theater during the ... MoMA,s senior curator of architecture and design, and ...
(Date:6/23/2016)... ... June 23, 2016 , ... Supplyframe, the Industry Network for ... Design Lab . Located in Pasadena, Calif., the Design Lab’s mission is to ... are designed, built and brought to market. , The Design Lab is Supplyframe’s ...
(Date:6/23/2016)... ... June 23, 2016 , ... In a new case report published today ... a patient who developed lymphedema after being treated for breast cancer benefitted from an ... paradigm for dealing with this debilitating, frequent side effect of cancer treatment. ...
(Date:6/23/2016)... June 23, 2016  Blueprint Bio, a company dedicated ... the medical community, has closed its Series A funding ... . "We have received a commitment from ... we need to meet our current goals," stated ... the runway to complete validation on the current projects ...
Breaking Biology Technology: