We hear a lot today about the pros and cons of
generic medications. the markets are flooded
with these medications and the name brand
companies warn the customers about using only
name brand. The truth of the matter is that most
generic brands in U.S. markets are just as good
if not the same as their name brand
counterparts. in order for readers to understand
it is best to start with the defenition of what
is a generic drug.A generic drug is
identical, or bioequivalent to a brand name drug
in dosage form, safety, strength, route of
administration, quality, performance
characteristics and intended use. Although
generic drugs are chemically identical to their
branded counterparts, they are usually sold for
much less in comparison to the branded ones.
According to the Congressional Budget Office,
generic drugs save american consumers an
estimated $8 to $10 billion a year on the retail
pharmacies level.
For drugs to be sold in pharmacies an and
stores in the U.S.A, Drug companies must submit
an abbreviated new drug application (ANDA) for
approval to market a generic product. their are
laws put into place for the protection of final
consumers, one is The Hatch-Waxman Act of 1984,
which made ANDAs possible by creating a
compromise in the drug industry. due to this law
Generic drug companies gained greater access to
the market for prescription drugs, and innovator
companies gained restoration of patent life of
their products lost during FDA's approval
process.
New drugs, like other new products, are
developed under patent protection. The patent
protects the investment in the drug's research
and development by giving the company that
develops it the right to be the only company
that sells the drug while the patent is still in
effect.
When the patents right period of exclusivity
expire, manufacturers admit an application to
the Federal Drug Administration to sell generic
versions of a particular brand name drug. The
ANDA process does not require the drug sponsor
to repeat costly animal and clinical research on
ingredients or dosage forms already approved for
safety and effectiveness when the brand name
drug was approved. This applies only to drugs
first marketed after 1962.
Health professionals and consumers must make
sure that the generic version on the shelvs in
their corner storesare FDA approved. this will
be mentioned on the container the drug is in.
Once they customers see the federal Drug
Administratiions seal on the box they can be
assured that iut is an FDA approved generic
drugs and that it met the same rigid standards
as the name brand drug. In order for a generic
to gain FDA approval, a generic drug must:
a) contain the same active ingredients as the
innovator drug (inactive ingredients may vary)
b) be identical in strength, dosage form, and
route of administration
c) have the same use indications
d) be bioequivalent
e) meet the same batch requirements for
identity, strength, purity, and quality
F) be manufactured under the same strict
standards of FDA's good manufacturing practice
regulations required for innovator products.
Generic medications are typically named for
the active ingredients that they contain. for
example the famous Viagra. Viagra is the brand
name registered under the application of the
innovater company pfizer. the generic name for
the drug is Vardenafil HCl, for the ingredients
contained in this perticular prescription
pharmaceutical. another good example is Propecia
and its generic counterpart Finasteride. In many
cases the same company that manufactures the
brand name drug will also produce the generic
equivalent inorder for them to maintain a market
share.
Now that you have learned what is a gerneric
medication, and what to look for before you make
a pyrchase, you may go ahead and share you newly
aquired knowledge with your friends, and
hopefully save large sums of money in the
process.
US based Marketing expert on B2C business,
now is the developer at
http://www.online-casinos-usa.com and
http://www.generapharm.com.
Article Source:
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