Cipla receives US FDA approval for generic Epzicom tabs

April 2017:

The tablets in combination with other antiretroviral agents are used for the treatment of HIV-1 infection

Cipla received final approval for its ANDA for Abacavir and Lamivudine tablets USP, 600 mg/300 mg, from the US FDA.

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.

Epzicom tablets had US sales of approximately $346.3 million for the 12 month period ending February 2017, according to IMS Health. The product will cater to the US market and will be commercially available shortly.