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.