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Corporate - Regulatory Bodies & Rulings
Aurobindo HIV drug gets FDA nod

Hyderabad, Dec. 22

Aurobindo Pharma Ltd has received tentative approval for its New Drug Application (NDA) Abacavir Sulfate / Lamivudine tablets in 60/30 mg from the US Food and Drug Administration (US FDA). The NDA provides for the use of Abacavir Sulfate/ Lamivuudine for treating HIV infections. The Hyderabad-based company had also secured registration from the Medicines Control Council (MCC), South Africa, to manufacture and market four products. The products, which are under the Central Nervous System (CNS), are Auropidone, Auropidone (tablet and solution), Auro-Risperidone (solution) and AuroSumatriptan (tablet), the Hyderabad-based company said in a release. - Our Bureau

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