Cipla gets US regulatory nod for generic Epzicom tablets
Mumbai: Global pharmaceutical company Cipla on Tuesday announced that it has received final approval of the US Food and Drug Administration (USFDA) for the generic version of Epzicom tablets — for the treatment of HIV-1 infection.
“Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, are AB-rated generic equivalents to the reference listed drug (RLD), Epzicom Tablets, 600 mg/300 mg of ViiV Healthcare Company and are indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection,” the company said in a statement.
“The product will cater to the US market and will be commercially available shortly,” it added.
According to IMS Health — the American firm that provides information, services and technology for the healthcare industry — Epzicom tablets had US sales of approximately $346.3 million for the 12-month period ending February.