A Medical Device Daily
The FDA has cleared the way for generic versions of transdermal patches to treat chronic pain with its approval late last month of Mylan Technologies' (St. Albans, Vermont) abbreviated new drug application.
The FDA granted approval to the Mylan Laboratories (Canonsburg, Pennsylvania) subsidiary for the first generic version of Alza's (Mountain View, California) 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, the patch technology delivers fentanyl, an opioid pain medication that is slowly absorbed into the body and provides pain relief for up to three days.
The agency's approval is expected to provide patients with access to a lower-cost alternative of this pain management system.
Mylan's Fentanyl Transdermal System is available in 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr strengths and will be shipped immediately.
In a Mylan Laboratories earnings conference call, Robert Coury, CEO and vice chairman of the board, called the approval “another first for Mylan.“
At the same time that the FDA approved Mylan's generic product, it acted on four citizens' petitions requesting that the agency deny or delay approval of certain generic versions of the Duragesic product. The petitions the FDA denied included one from Alza, which holds the Duragesic patent (Medical Device Daily, Feb. 3, 2005).
The original Fentanyl Transdermal System was approved in 1990 and is marketed in the U.S. by Janssen Pharmaceutical Products (Titusville, New Jersey), which, like Alza, is a Johnson & Johnson (New Brunswick, New Jersey) company.
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.
Other companies hoping to manufacture generic fentanyl patches include Noven Pharmaceuticals (Miami) (MDD, Dec. 14, 2004), whose abbreviated new drug applications is pending at the FDA.
Fentanyl is 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 the DEA with input on medical need from the FDA, distribution tracking, import and export controls, registration of prescribers and dispensers, and written prescriptions without refills.
U.S. distribution rights go to Zimmer
Zimmer Holdings (Warsaw, Indiana), a worldwide leader in the orthopedics industry, said it has acquired U.S. distribution rights for the Palacos line of bone cement products manufactured by Heraeus Kulzer (Hanau, Germany), a producer of orthopedic bone cement products and other healthcare technologies.
The Palacos line is a recognized market leader in cemented orthopedic surgical procedures, Zimmer said. Under the new distribution agreement, it expects to begin selling Palacos and other Heraeus Kulzer bone cements in 2Q05 following an introduction at this month's American Academy of Orthopaedic Surgeons meeting, and will become the exclusive U.S. distributor for these products in January 2006.