| A. |
Yes.
In September of 2000, the Food and Drug Administration
(FDA) approved
ONXOL as safe and effective for use as recommended
in the product labeling and
gave the product an AP rating. For an injectable
solution, like ONXOL, an AP
rating indicates that the product is therapeutically
equivalent to the brand
reference. FDA believes that products classified
as therapeutically equivalent
can be substituted with the full expectation that
the substituted product will
produce the same clinical effect and safety profile
as the brand reference.
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