Aurobindo Pharma has won the final FDA approval to manufacture and market its generic anti-Human Immunodeficiency Virus (HIV) drug, Abacavir Tablets USP 300mg.
Abacavir, the generic version of ViiV Healthcare Company's Ziagen Tablets 300mg, is used to treat HIV infected adults and children as a part of antiretroviral (ARV) combination therapy.
The product that has been approved out of its Hyderabad Unit III formulations facility is ready for launch, according to the company.
Each Ziagen tablet contains abacavir sulfate equivalent to 300mg of abacavir as active ingredient in addition to inactive ingredients such as colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Source:
http://regulatoryaffairs.pharmaceutical-business-review.com/news/aurobindo-wins-fda-nod-for-generic-anti-hiv-drug-191212
