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 The health regulator in October declined to approve the intravenous
formulation of the painkiller, stating it was not safe for the
intended population.
The agency said on Monday the delayed and unpredictable onset of
analgesia - relief from pain - with intravenous (IV) tramadol did
not support its benefit as a monotherapy to treat patients with
acute pain.
There was also insufficient data to support that IV tramadol was
safe and effective in combination with other drugs, FDA said in its
decision that came in more than two months after the scheduled date
of April 12.
H.C. Wainwright analyst Joseph Pantginis, however, says that IV
tramadol could still have a path forward.
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The FDA did not mention any "chemistry, manufacturing and controls
(CMC)" issues in its complete response letter, Avenue said, adding
that it disagreed with the agency's decision and would continue to
seek regulatory approval for IV tramadol.
Tramadol was approved in the United States in 1995 as a
non-controlled analgesic, under the trade name of Ultram, to be sold
by drugmaker Johnson & Johnson.
(Reporting by Trisha Roy in Bengaluru; Editing by Rashmi Aich and
Shinjini Ganguli)
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