Business Daily from THE HINDU group of publications
Tuesday, Aug 01, 2006
Business Daily from THE HINDU group of publications Tuesday, Aug 01, 2006 |
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Corporate
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Regulatory Bodies & Rulings Aurobindo's combination drug gets US FDA nod Our Bureau
Hyderabad , July 31 Aurobindo Pharma Ltd has received the tentative new drug application (NDA) approval for fixed drug combination product containing lamivudine 150 mg + 2idovudine 300 mg tablets co-packaged with abacavir 300 mg tablets (NDA) used in the treatment of HIV-1 infection. The three drugs are now available in one single pack. In a press release here on Monday, the company said this fixed drug combination pack comprises two-nucleoside reverse transcriptase inhibitors and a non-nucleoside reverse transcriptase inhibitor and is used in HIV treatment. . With the approval of such a combination by the United States Food and Drug Administration , several patients under the US President's Emergency Programme for AIDS Relief programme would be benefited. The company said this is the first NDA generic approval in the world for a three-drug combination pack. The company said it is vertically integrated in the active pharmaceutical ingredients and formulation for this product.
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