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www.aurobindo.com |
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Hyderabad, 21st September, 2005 |
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US FDA GRANTS APPROVAL FOR
AUROBINDO'S ZIDOVUDINE |
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We are extremely happy to inform that US FDA has
given the final approval for Aurobindo’s
tentatively approved products, namely Zidovudine
Tablets 300 mg and Zidovudine Oral Solution 50
mg/5 ml. |
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The US FDA has given these approval on the same
day. US FDA has taken this initiative in view of
innovator patent expiry on 17th September 2005.
Zidovudine Oral Solution 50 mg/5 ml is the first
Oral Solution approval for Aurobindo Pharma
Limited. |
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Aurobindo is also proud to share that it is the
first generic company to have final approval for
Zidovudine Oral Solution 50 mg/5 ml. It is one
of the significant achievement for Aurobindo
Pharma Limited. With these two final approvals,
Aurobindo has added some more products to sell
in the regulated market. |
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AZT, an anti-retroviral drug that is also known
as Zidovudine, helps prevent the AIDS virus from
reproducing in the body. It is often used in
combination with other medications to treat an
HIV infection. Zidovudine is in the class of
drugs called nucleoside reverse transcriptase
inhibitors (NRTIs). It is intended to be used
with other antiretroviral agents for the
treatment of HIV-1 infection. This product
contains 50 mg/5 ml of zidovudine in an oral
solution. |
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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
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