New FDA Approvals
These drugs were recently approved by the FDA:
• Generic Fentanyl Transdermal System (Duragesic Patch) by Mylan Technologies. The FDA has approved the first generic version of Alza Corp.’s Fentanyl Transdermal System (Duragesic Patch), which is 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 the FDA approved Mylan’s generic product, it acted on several citizens’ petitions requesting that the FDA deny or delay approval of the product.
The original Fentanyl Transdermal System was approved in 1990. It currently is approved for the management of chronic pain in patients who require continuous opioid analgesia for pain that cannot be managed by acetaminophen-opioid combinations, nonsteroidal analgesics, or as-needed dosing with short-acting opioids.
Fentanyl currently is a Schedule II controlled substance. 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). Schedule II drugs are subject to manufacturing quotas set by 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.
• Full approval for doxorubicin HCl liposome injection (Doxil) by Tibotec Therapeutics. The FDA has granted full approval to doxorubicin HCl liposome injection (Doxil) for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. Doxorubicin originally received accelerated approval for refractory ovarian cancer in June 1999. As a result of the full approval, the product label for the drug has been updated to include survival, time-to-disease progression, and tumor response rate data from a randomized Phase III clinical study.
Under accelerated approval, doxorubicin was indicated for the treatment of metastatic ovarian cancer in patients with disease that was refractory to both paclitaxel- and platinum-based chemotherapy regimens. This approval was based on tumor response rates from three Phase II studies.
According to the terms of the accelerated approval, Johnson & Johnson Pharmaceutical Research & Development LLC (J&JPRD) completed a randomized Phase III clinical study to formally demonstrate the drug’s clinical benefit in patients with relapsed ovarian cancer. In March 2004, J&JPRD submitted a supplemental new drug application based on data from the Phase III study.
In clinical studies in recurrent ovarian cancer, the most common side effects reported with doxorubicin therapy included hand-foot syndrome, nausea, mouth sores, tiredness, abdominal pain, vomiting, constipation, rash, fever, reduced red blood cell count, reduced white blood cell count, weakness, hair loss, appetite loss, and diarrhea. Some patients experienced infusion-related reactions and skin reactions. In some patients enrolled in doxorubicin clinical trials, heart-related side effects were reported, some of which were severe. Due to the serious, potentially permanent effects of some of these events, including the potential for bone marrow suppression, close monitoring is necessary.
Generic Fentanyl Transdermal System (Duragesic Patch) by Mylan Technologies and Full approval for doxorubicin HCl liposome injection (Doxil) by Tibotec Therapeutics.Subscribe Now for Access
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