Mumbai: Aurobindo Pharma has received tentative approval from the US Food and Drugs Administration (USFDA) to manufacture and market its fixed dose combination Abacavir Sulfate / Lamivudine tablets 60/30mg.
The new drug application (NDA) 22-295 provides for the use of abacavir sulfate/lamivudine tablets 60/30mg for the treatment of HIV infections, Aurobindo Pharma said in a filing with the Bombay Stock Exchange.
Abacavir sulfate tablets are used with other antiretroviral drugs in the treatment of HIV infection in adults and children above 3 months of age.
Lamivudine is used for the treatment of chronic hepatitis B at a lower dose than for treatment of HIV.
The new drug application (NDA) 22-295 provides for the use of abacavir sulfate/ lamivudine tablets 60/30 mg for the treatment of HIV infections.
The company had earlier received tentative approvals to co-packaged lamivudine/zidovudine tablets + abacavir sulfate tablets 150/300mg + 300mg and abacavir sulfate / lamivudine tablets 600/300 mg
This is Aurobindo's 87th ANDA approval from USFDA (61 final approvals, 26 tentative approvals), the company siad in the statement.
Hyderabad-based Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients at its facilities approved by several leading regulatory agencies like US FDA, UK MHRA, WHO, Health Canada, MCC South Africa, ANVISA Brazil.
The company has a robust product portfolio spread over six major therapeutic/product areas encompassing antibiotics, anti-retrovirals, CVS, CNS, gastroenterologicals, and anti-allergics.
Aurobindo Pharma markets drugs in over 100 countries.