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Aurobindo Receives Approval from USFDA for anti-AIDS drug

AIDS patients, the world over, can heave a sigh of relief following the nod of approval from the US Food & Drug Administration// (FDA) for the world’s first anti-AIDS cocktail drug for use as a single dose.

The drug manufacturer, Hyderabad-based bulk drugs major Aurobindo Pharma, has made combined anti-retro virals (ARVs) — Retrovir (zidovudine), Epivir (lamivudine) and Viramune (nevirapine) into a single three-in-one fixed dose drug.

The World Health Organisation (WHO) recognizes the three drugs as the first line of therapy for AIDS and they constitute about 50% of drug therapy against the disease.

Therefore the combination of the three drugs as a single tablet will result in fewer dosages as well as side-effects making life much easier for patients. Otherwise these patients have to consume about 20-30 pills a day for the Highly Active Antiretroviral Therapy (HAART) in treating AIDS.

With the US FDA approval means the drug can be sold immediately in over 15 countries as part of the $15 billion US President’s Emergency Plan for AIDS Relief (PEPFAR) programme.

Besides this, since the combination drug has now become a new drug it can receive new drug approval (NDA) and sold in the US markets, once the patents on the individual components expire. The combined market for these three drugs is estimated at a whopping $5 billion annually in the US alone.

The patents for these drugs in the US market expire in 2009 and 2010.

According to Lanka Srinivas, director, Aurobindo Pharma, 'This is indeed a major milestone for Aurobindo and, in fact, the whole country. What is further significant is that this is the first triple combination filing approved by the US FDA and, in fact, the first one ever filed.'

Lanka added that Aurobindo is targeting over $100 million in total revenues from the export of ARVs next year from the current $60 million.


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