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www.aurobindo.com |
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Hyderabad, 3rd September, 2005 |
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AUROBINDO RECEIVES TENTATIVE
APPROVAL FOR ZIDOVUDINE TABLET |
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We are pleased to inform that the
US FDA has granted tentative approval for
Aurobindo’s zidovudine 300 mg tablets. |
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This approval by US FDA makes Aurobindo to
qualify under the President's Emergency Plan for
AIDS Relief (PEPFAR) program for the above
tablet. |
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Since zidovudine is going off patent this month,
this tentative approval may lead to final
approval that will allow Aurobindo to sell the
same in the US Market.
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US FDA already granted tentative approval to a
generic combination drug product manufactured by
Aurobindo consisting of Lamivudine 150 mg and
Zidovudine 300 mg. |
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Zidovudine is a nucleoside reverse transcriptase
inhibitor (NRTIs), 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
