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www.aurobindo.com |
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Hyderabad, 3rd July, 2005 |
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AUROBINDO ANNOUNCES APPROVAL OF
STAVUDINE TABLETS |
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Aurobindo Pharma Limited is delighted to share
that the Company has received final approval
from the US FDA for Stavudine tablets, 30 mg and
40 mg. This is once again, a first generic
approval received by Aurobindo Pharma. This is
the fourth ARV ANDA approved by US FDA. The
Company has already received approval for
Nevirapine, Lamivudine and Efavirenz. |
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Stavudine is an antiviral agent of the
nucleoside analog class, which includes
zidovudine (AZT), didanosine (ddI) and
zalcitabine (ddC). The international brand name
is Zerit and is marketed by Bristol Myers
Squibb. Nucleoside analogs are thought to slow
the progression of AIDS by inhibiting HIV
replication. Data indicate that this class of
drugs may delay the onset of AIDS symptoms in
HIV-infected individuals, and may extend
survival in some. |
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The drug will now be available for consideration
for purchase under the President’s Emergency
Plan for AIDS Relief (PEPFAR), a five-year
program being run to fight HIV/AIDS pandemic.
The Emergency Plan for AIDS Relief, which
President Bush announced, currently provides
USD15 billion to fight the HIV/AIDS over five
years, with a special focus on 15 of the
hardest-hit countries. The PEPFAR plan is
designed to prevent seven million new HIV
infections, treat at least two million
HIV-infected people, and care for ten million
HIV-affected individuals, AIDS orphans and
vulnerable children. |
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About Aurobindo Pharma Limited |
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Aurobindo Pharma Limited (www.aurobindo.com),
headquartered at Hyderabad, India, manufactures
generic pharmaceuticals and Active
Pharmaceutical Ingredients. The Company has
received approvals for several facilities from
leading regulatory agencies like US FDA, UK MHRA,
WHO, Health Canada, MCC South Africa. The
company’s robust product portfolio is spread
over 6 major therapeutic/product areas
encompassing (Antibiotics, Anti-Retrovirals,
CVS, CNS, Gastroenterologicals, and Anti-Allergics)
around 65 APIs in the non-antibiotics and 55
APIs in the antibiotic segment. The Company is
marketing these products globally, in over 100
countries. |
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