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www.aurobindo.com |
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Hyderabad, 12th July, 2005 |
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AUTOBINDO PHARMA GETS US FDA NOD
FOR LAMIVUDINE AND ZIDOVUDINE COMBINATION TABLETS |
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Aurobindo Pharma has been granted
the tentative approval for the ANDA drug
lamivudine and zidovudine
tablets, 150 mg / 300 mg
with combination.
This is once again a significant achievement for
Aurobindo Pharma in terms of formulation
technology. It is the first generic version of
Glaxo SmithKline Plc's combination AIDS drug
Combivir. This will also enable Aurobindo to
participate in President's Emergency Plan for
AIDS Relief (PEPFAR) program. This is one of the
popular combination prescribed by doctors around
the world and it is one of the largest seller in
the ARV (Anti-Retroviral) segment. |
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Lamivudine and zidovudine are in the class of
drugs called nucleoside reverse transcriptase
inhibitors (NRTIs), which help keep the AIDS
virus from reproducing. This fixed-dose
combination anti-retroviral drug is intended to
be used with other antiretroviral agents for the
treatment of HIV-1 infection. |
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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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PRESS
ROOM
