The company secured final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA)for Lamivudine Tablets to treat chronic hepatitis B virus infection associated with evidence of hepatitis B viral replication and active liver inflammation.
According to IMS Health, Lamivudine Tablets, 100mg, had US sales of around $18.1m for the 12 months ending 30 September 2014.
Around 284 of the comapny’s ANDAs are still awaiting clearance from the US FDA that represent $109.1bn in annual sales, with 44 of them being potential first-to-file opportunities, signifying $29.3bn in annual brand sales, for the year ending 30 June 2014.
The company provides a growing portfolio of more than 1,300 generic pharmaceuticals and several brand medications.
Additionally, the company provides a wide range of antiretroviral therapies, upon which about 40% of HIV/AIDS patients in developing countries depend.
The company also operates one of the largest active pharmaceutical ingredient manufacturers and currently markets products in about 140 countries and territories.