Cephalon, maker of the potent pain killer Fentora, has filed a citizen petition to the Food and Drug Administration (FDA) claiming that Watson Pharmaceutical’s copycat version of Fentora differs chemically from Fentora and thus should have to go through a lengthier approval process reserved for new drugs rather than the shorter process reserved for generic drugs. This is Cephalon’s latest attempt to block generic competition for Fentora, which had sales of $87 million during the first six months of 2010. 

Fentora was approved by the Food and Drug Administration (FDA) in 2006 for the limited use of treating breakthrough pain in cancer patients already treated with round-the-clock opioids. Patients who use Fentora and Cephalon’s similar opioid Actiq without first being opioid-tolerant are at risk of severe side effects including respiratory distress and death.

Despite the warnings, as much as 80 percent of prescriptions for Fentora and Actiq are for treatments not approved by the FDA, such as headaches, backaches and chronic pain. While doctors can write prescriptions for off-label uses, drug companies are forbidden to promote uses that are not FDA approved. An investigation into the skyrocketing off-label sales and adverse events associated with Fentora and Actiq revealed that Cephalon had paid doctors to talk about the unapproved uses of the powerful opioids with other physicians.  

Cephalon claims that Watson’s generic version of Fentora doesn’t qualify as a generic because it contains two active ingredients – fentanyl citrate and fentanyl starch glycolate – whereas Fentora only contains one active ingredient – fentanyl citrate.

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