Fentanyl approval
January 11, 2011
WATSON Pharmaceuticals’ has
received US Food and Drug
Administration approval for its
generic Fentanyl Buccal tablets,
USP, in the 0.1, 0.2, 0.4, 0.6 and
0.8 mg strengths, for the
management of breakthrough pain
in cancer patients aged 18 years
and over.
The move marks the first generic
version approval for the drug, and
as such may entitle Watson to a
180-day market exclusivity period.
Cephalon, maker of the original
Fentora tablets, is still however
holding out hope that it will win its
current lawsuit against Watson
regarding the new generic, and
claims that it infringes several
existing Cephalon patents.
At present a verdict on the case
is still pending in the US court
system, and Watson has been
ordered to hold off on launching
the generic until a decision has
been handed down.
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