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First Generic Version of Dolutegravir Approved by the FDA

September 23, 2016

Aurobindo Pharma receives US FDA tentative approval for dolutegravir -- the first generic version to be approved.

This generic dolutegravir is expected to be launched in sub-Saharan Africa in late 2016 through a collaboration between Aurobindo, ViiV Healthcare, and the Clinton Health Access Initiative (CHAI).

The WHO included dolutegravir in its most recent first-line recommendations. Tentative approval allows this version to be used in PEPFAR programmes.

Aurobindo dolutegravir is bioequivalent and therapeutically equivalent to the reference originator product manufactured by ViiV.

ViiV and Aurobindo signed a licensing agreement in 2014 that allows Aurobindo to supply dolutegravir 50mg in 92 licensed countries, following local regulatory approval. The generic version will be launched around three years from the approval of the originator product.


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Aurobindo currently have approval for dolutegravir in Kenya and are expecting approvals in several other countries in the coming months.

The single pill will be launched at an annual patient cost of around US$ 44. 

Dolutegravir-based generic fixed dose combination products are not far off.

This is a milestone to better treatment globally and greater equity between the highest and lowest income countries. The latest ARV -- and most effective one -- will match generic efavirenz for price.

This will give real choice for second-line treatment and will give all low income countries access to third-line treatment for the first time.

We now need a deal for middle-income countries.


Reference

Press Release: Aurobindo Pharma receives USFDA tentative approval for dolutegravir. 22 September 2016.
www.clintonhealthaccess.org/usfda-tentative-approval-dolutegravir




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