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Generic ARV gets tentative approval from FDA

    JOHANNESBURG

    Indian pharmaceutical company Ranbaxy has received 'tentative approval' from the US Food and Drug Administration (FDA) for its generic version of an antiretroviral (ARV) drug.

    Lamivudine (3TC) is the first ARV from an Indian manufacturer to be approved by the US drug regulator for purchase by the President's Emergency Plan for AIDS Relief (PEPFAR), the KaiserNetwork news service reported.

    This means that the medication is considered equivalent to the patented product and can be used in the $15 billion PEPFAR programme, which directs money to 12 African nations and the Caribbean.

    The FDA has expedited its review procedure for ARVs to allow the US government to purchase cheaper versions of the life-prolonging medication.

    This article was produced by IRIN News while it was part of the United Nations Office for the Coordination of Humanitarian Affairs. Please send queries on copyright or liability to the UN. For more information: https://shop.un.org/rights-permissions

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