Urine test approval
February 16, 2012
THE first molecular test to help
determine the need for repeat
prostate biopsies in men who have
had a previous negative biopsy,
PROGENSA PCA3 (Prostate Cancer
gene 3) assay, has been approved
by the US Food and Drug
Authority.
The FDA has also approved
Zioptan (tafluprost ophthalmic
solution) to help reduce elevated
eye pressure in people with openangle
glaucoma.
MEANWHILE the publication of
three biosimilar guidance
documents by the FDA has been
welcomed by industry members.
“The documents provide the
infrastructure by which
pharmaceutical manufacturers can
seek approval for lower cost,
clinically comparable alternatives
to some of the most commonly
utilised biologic agents purchased
by health care organisations,” said
health care supply contracting
company, Novation.
“In recent years, an increasing
amount of hospital pharmaceutical
expense is being devoted to the
acquisition of high cost, large
molecule biologics, which
historically have not been subject
to “generic” competition because
they are complex to manufacture
and are derived from living
organisms.
“Biosimilars, or drugs that clinical
studies deem “highly similar” to
these large molecule biologics, will
provide effective, safe, and costefficient
alternatives to expensive,
current biologic drugs,” the
company added.
See www.fda.org.
The above article was sent to subscribers in Pharmacy Daily's issue from 16 Feb 12To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 16 Feb 12
