Di-Gesic saga continues
November 9, 2012
THE TGA has issued a statement
on the status of
dextropropoxyphene-containing
medicines, saying proceedings
regarding the cancellation of Di-
Gesic and Doloxene have resumed
before the Administrative Appeals
Tribunal (AAT) and the matter has
been set down for a final hearing
on 27 and 28 February 2013.
The news follows the ongoing
cancellation saga of the medicines,
which began in Dec 2011, and
which most recently, on 12 Sep saw
the TGA affirm the decision to
cancel Di-Gesic and Doloxene after
it found that the safety of those
medicines was unacceptable.
“Consistent with the intentions of
the AAT in remitting the matter for
reconsideration, the TGA considered
various proposals put forward by
the sponsor of the medicines that
would allow the medicines to stay
on the ARTG,” the TGA said.
“The TGA was not satisfied that
the proposals would address the
safety issues identified,” the TGA
added.
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