Macleods Receives Tentative Approval for HIV Drug

6 September 2010 (Last Updated September 6th, 2010 18:30)

Macleods Pharmaceuticals has received tentative approval from the Food and Drug Administration (FDA) for a fixed dose combination formulation of lamivudine, nevirapine and stavudine tablets. The 150mg/ 200mg / 30mg fixed-dose tablets for the treatment of the HIV-I infection are indicat

Macleods Pharmaceuticals has received tentative approval from the Food and Drug Administration (FDA) for a fixed dose combination formulation of lamivudine, nevirapine and stavudine tablets.

The 150mg/ 200mg / 30mg fixed-dose tablets for the treatment of the HIV-I infection are indicated for use alone or in combination with other antiretroviral drugs.

Tentative FDA approval means that even though 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 president's emergency plan for Aids relief.

The fixed-dose combination of tablets is manufactured at the company's facility in Daman, India.