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www.aurobindo.com |
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Hyderabad, October 9, 2006 |
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US FDA
approval for Didanosine Oral Suspension |
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Aurobindo takes pleasure to
inform that the US FDA has granted tentative
approval for Aurobindo’s Didanosine Oral
Suspension (Pediatric Powder) 10 mg / ml. |
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This product is the first generic
version of the research product, Videx Pediatric
Powder for Oral Suspension, 10-mg/ml,
manufactured by Bristol Myers Squibb
Pharmaceuticals. |
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The aforesaid product will now be
available for consideration for purchase under
the PEPFAR. Aurobindo manufactures both API and
formulation for this generic.
With this approval the Company
has 32 products approved by USFDA (inclusive of
tentative approvals) and 17 of them are ARVs. |
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It is indicated for use in
pediatric patients with HIV. |
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Didanosine is active against the
human immunodeficiency virus (HIV) that causes
AIDS. It is in the class of drugs called
nucleoside reverse transcriptase inhibitors (NRTIs),
which helps keep the AIDS virus from
reproducing. It is used in combination 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’s robust
product portfolio is spread over 6 major
therapeutic/product areas encompassing
(Antibiotics, Anti-Retrovirals, CVS/ Statins/Diabetology,
CNS, Gastro/Uro/Kidney therapeutics, Anti
fungal/ allergics/respiratory) around 65
Betalactam APIs and 123 Non-Betalactam APIs.
The Company markets its products
in over 100 countries. The company has filed
over 65 ANDAs and 88 DMFs for the USA market, in
addition to several filings in other countries.
The company has received approvals for several
facilities from leading regulatory agencies like
US FDA, UK MHRA, WHO, Health Canada, MCC South
Africa. |
For further information,
please contact:
Investor Relations
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar | Ameerpet
Hyderabad - 500 038 |India
Phone (Board): +91 40 5572 5000
Email : ir@aurobindo.com |
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