Cipla Ltd, a global pharmaceutical company, announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Abacavir and Lamivudine Tablets USP, 600 mg/300 mg, from the United States Food and Drug Administration (USFDA).
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 $346.3M 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.
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