UPDATE 1-US panel rejects Oscient antibiotic for sinusitis
Tue Sep 12, 2006 4:39pm ET162
By Susan Heavey

GAITHERSBURG, Md., Sept 12 (Reuters) - Oscient Pharmaceuticals Corp.'s
(OSCI.O: Quote, Profile, Research) Factive antibiotic is not safe and
effective enough to treat acute sinus infections based on current data,
a U.S. advisory panel said on Tuesday.

Oscient is seeking wider U.S. Food and Drug Administration approval of
the drug to treat sinusitis infections over a five-day period. Factive
is already approved for community-acquired pneumonia and certain cases
of chronic bronchitis.

Some of the FDA's panelists said they thought the drug would work. But
in a 10-4 vote, the panel said current data comparing Factive to similar
drugs did not show it worked against the infections, known as sinusitis.

Overall, the risk of rashes and other side effects outweighed any
possible benefit, the panel said in a final 12-2 vote. An FDA staffer
later corrected the vote as 11-2, with one abstention.

The FDA sought the advice of its outside experts on whether to approve
the drug for sinusitis, but is not bound by their vote. A final agency
decision is expected by Dec. 15.

FDA officials have previously rejected Factive for sinus infections
because of the risk of rash, which is higher in patients younger than
40, especially women.

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