Sunday, January 22, 2012

MicroLab receives tentative approval for Sustiva - May Dent BMY's Sustiva Revenues Ahead of Time

MicroLabs has received tentative approval from the USFDA for Sustiva.  The US Sales of Sustiva are  $900m and the global sales are about $1.5b. It is not clear when MicroLab may be able to sell Sustiva in the US markets as Sustiva patents have not been challenged. This tentative approval means that, although the product meets all the safety, efficacy and manufacturing quality standards, it cannot be marketed in the US, but it does qualify for consideration for purchase under the PEPFAR.  The US Agency for International Development may purchase any product that has either a ‘full’ or ‘tentative’ FDA approval for use in developing countries. It seems the drug may significantly dent Sustiva revenues for BMY going forward..