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Aurobindo Receives Us FDA Approval For Yet Another 3 In 1 ARV Combination First Generic NDA Of Its Kind |
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01 Aug 2006 |
HYDERABAD, India | Jul 31, 2006 | Aurobindo is delighted to share that the company has received the tentative NDA approval for fixed drug combination product containing Lamivudine150mg+Zidovudine300mg tablets co packaged with Abacavir 300mg Tablets (NDA) used in the treatment of HIV-1 infection. The three drugs are now available in one single Pack.
This fixed drug combination pack comprising two-nucleoside reverse transcriptase inhibitor (NRTIs) and a non-nucleoside reverse transcriptase inhibitor (NNRTIs) is used in several HIV patients. In many parts of the world, the regimen containing Lamivudine, Zidovudine and Abacavir is popular. 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.
This is the first NDA generic approval in the world for a three-drug combination co pack. Aurobindo is vertically integrated in the APIs and formulation for this product. These three drugs command over six hundred million-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 18 including 3 NDA approvals.
About Aurobindo Pharma Limited:
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 62 ANDAs and 67 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 :
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SOURCE: Aurobindo Pharma Limited |
