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Senior Health & Medicine
FDA Approves Generic Cholesterol and Leg Pain Drugs
Encouraging news for senior citizens needing to
save on drugs
April 25, 2006 Numerous studies have shown senior
citizens can save tremendous amounts of money by using generic drugs,
even in the Medicare prescription drug program. The Food and Drug
Administration today announced approvals for two generics that will be
of interest to many older people. The first, Pravastatin, is a generic
version of the cholesterol-lowering drug Pravachol. The second,
Cilostazol, is a generic for Pletal, which is prescribed for those who
get pain in the legs when walking.
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The FDA said Pravastatin Sodium Tablets is the
first generic version of Bristol-Myers Squibb's Pravachol and described
the action as "important step in the agency's effort to increase the
availability of lower-cost generic medications."
Pravastatin is for the treatment of individuals
with high cholesterol levels (hyperlipidemia) or who are at increased
risk for atherosclerosis-related cardiac and cardiovascular events, such
as heart attack and stroke in which high cholesterol levels are a
factor.
In 2005, Pravachol was the 22nd highest-selling
brand-name drug in the United States, with sales totaling $1.3 billion.
"This approval is another example of our agency's
endeavor to counter rising health care costs by approving safe and
effective generic alternatives as soon as the law permits," said Dr.
Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs.
"Pravastatin is a widely-used cholesterol-lowering agent, and its
generic version can bring significant savings to the millions of
Americans with this disease."
Generic drug products are used to fill over 50
percent of all prescriptions and since they cost a fraction of the price
of brand name drugs, the economic impact of FDA's generic drug program
is profound.
"With this in mind," says the FDA, "the Office of
Generic Drugs (OGD) continues working expeditiously to review and take
action on generic drug applications as quickly as possibly. In addition
there are several process improvements underway at the Agency to
facilitate in the review of generic drug applications."
Among other initiatives, OGD is considering several
simple, yet innovative new policies that could lead to the overall
reduction of review time. These include new review formats which allow
for overall risk assessments for individual applications in order to
dictate the level of OGD review need for subsequent product changes.
When fully implemented this has the potential to reduce supplements by
80 percent and reduce office expenditures of time and money.
The Bristol-Myers Squibb's patent for the drug
expired on April 20. Pravastatin Sodium Tablets (10mg, 20mg and 40mg)
are manufactured by TEVA Pharmaceuticals in Kfar Sava, Israel.
About Cilostazol Tablets
Mylan Laboratories Inc. made the first announcement
today that Mylan Pharmaceuticals Inc. has received final approval from
the FDA for its Abbreviated New Drug Application (ANDA) for Cilostazol
Tablets, 50mg and 100 mg. Cilostazol Tablets are the AB-rated generic
equivalent of Otsuka Pharmaceutical's Pletal(R) Tablets, which had U.S.
sales of approximately $84 million for the 12-month period ending
December 31, 2005, according to IMS Health.
This new generic will be shipped immediately, the
company said.
About Cilostazol (Pletal), the FDA said, it "is a
drug for the treatment of intermittent claudication (pain in the legs
that happens when walking and goes away with rest). It allows people
with this condition to exercise longer before developing their
characteristic leg pain and to walk longer before they must stop because
of the pain. Cilostazols mechanism of action is not clear.
"It is an inhibitor of phosphodiesterase III (PDE
III), which causes it to be a vasodilator and inhibitor of platelet
aggregation, these actions may contribute to its effect, but other drugs
with those properties are not known to be useful in intermittent
claudication."
The conclusion by the FDA said, "Consideration of
cilostazol raised complex benefit/risk considerations. Clearly effective
for a debilitating condition whose current treatment is often
inadequate, cilostazol is a member of a pharmacologic class that is
dangerous to people with severe heart failure and unstudied in other
people. Cilostazol has been studied in people without heart failure,
without evidence of harm, but much more data would be needed to
determine that there is no risk at all.
"Although cilostazol would not be approvable for a
trivial condition the Cardio-Renal Advisory Committee and FDA concluded
that fully informed patients and physicians should be able to choose to
use it to treat intermittent claudication. Patient and physician
labeling will describe the basis for concern and the incomplete
information available."
People with congestive heart failure should not
take this drug.
Mylan Laboratories Inc. (NYSE:MYL)
says it is a leading pharmaceutical company with three principal
subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and
UDL Laboratories, Inc., that develop, license, manufacture, market and
distribute an extensive line of generic and proprietary products. For
more information about Mylan, visit www.mylan.com.
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