FDAnews
www.fdanews.com/articles/89978-south-african-mcc-approves-aurobindo-s-generic-heart-drug

SOUTH AFRICAN MCC APPROVES AUROBINDO'S GENERIC HEART DRUG

February 21, 2007

Aurobindo Pharma has received another marketing authorization approval from the South African Medicines Control Council (MCC), this time for generic lisinopril tablets in 5-, 10- and 20-mg strengths.

Lisinopril, marketed by AstraZeneca as Zestril, is an angiotensin converting enzyme (ACE) inhibitor for the treatment of hypertension, congestive heart failure and acute myocardial infarction. According to Aurobindo, ACE inhibitors command a market value of $27 million in South Africa.

Aurobindo considers the South African market to be very important in its geographical region. In recent months the company has won MCC approval for its generic versions of several antiretroviral drugs, including stavudine, lamivudine and nevirapine, along with combination tablets.

The MCC granted approval to the company's manufacturing facility in Hyderabad, India, in September 2006.