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www.aurobindo.com |
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Aurobindo receives US FDA
approval for 3 in 1 ARV Combination.
First NDA Generic approval in HIV's by US FDA |
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Aurobindo is
delighted to share that the company has received
the first tentative NDA approval for fixed dose
combination drug product containing
Lamivudine+Zidovudine+Nevirapine
Tablets (NDA) used in the
treatment of HIV-1 infection. The three drugs
are now available in one single
tablet and the company is the sole
manufacturer of this approved combination. |
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This fixed dose combination
pill comprising two-nucleoside reverse
transcriptase inhibitor (NRTIs) and a
non-nucleoside reverse transcriptase inhibitor (NNRTIs)
is used as a first line therapy in most HIV
patients. In most parts of the world, the
regimen containing Lamivudine, Zidovudine and
Nevirapine is very popular. The need for a
proven, stable, bioequivalent fixed dose
combination is acutely felt. Such therapy
enhances the convenience & compliance, is cost
effective and reduces the threat of resistance
due to missed doses. With the approval of such a
combination by USFDA, several patients under
PEPFAR programme will be immensely benefited. |
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This is the first
NDA generic approval in the world (innovator
doesn't have this fixed dose combination) for a
three-drug combination (amongst ARVS). Aurobindo
is vertically integrated in the APIs and
formulation for this product. |
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With this approval Aurobindo
has once again demonstrated its capabilities of
formulation development skills in developing and
stabilizing such difficult combinations. The NDA
Approval is an important milestone in the
learning curve of Aurobindo. These three drugs
command 4.5 billion dollar market worldwide and
the usage of the drugs is growing due to the
outstanding commitment of the US Govt. in
particular and the WHO to rehabilitate HIV
patients. With this approval, the ARV product
portfolio of Aurobindo has increased to 15
including 2 NDA approvals. |
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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. |
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The Company markets
its products in over 100 countries. The company
has filed over 50 ANDAs and 69 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. |
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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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Unit
Certifications |
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Unit |
Certifications |
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API |
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Unit I |
US FDA |
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Unit 1 A |
US FDA |
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Unit VI A |
Health Canada, US FDA
(pre approval over) |
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Unit VIII |
US FDA, WHO |
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Unit XI |
US FDA |
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Formulations |
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Unit III |
US FDA, UK MHRA,
WHO, Health Canada, MCC (SA), Brazil Anvisa
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Unit VI B |
US FDA, MCC (SA), Health
Canada, Brazil Anvisa |
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Unit XII |
US FDA, Health
Canada, UK MHRA, Brazil Anvisa
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PRESS
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