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A generic
version of the drug Fosamax has been tentatively approved
by the U.S. Food and Drug Administration for the treatment
and prevention of osteoporosis but it still will take some
time before it is on the market.
Merck
& Co, makers of Fosamax, filed suit in August 2001 to
prevent Barr, makers of the generic version, from marketing
their 70 mg dose of the drug. Merck also filed suit in December
2001 to prevent Barr from selling a 35 mg dose of the drug.
Barr's challenge of Merck's patents is currently pending in
the U.S. District Court for the Southern District of New York.
Fosamax
is used for the treatment and prevention of osteoporosis in
postmenopausal women and for the treatment to increase bone
mass in men with osteoporosis.
A tentative
approval shows the FDA's preliminary determination that a
generic product satisfies the requirements for approval, subject
to the expiration of patents. The action does not allow Barr
to market the generic drug product.
Source:
Medical Week staff,
week of May 5, 2002
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