Cipla Receives approval for Generic Epzicom® Tablets
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).
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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 6.3M 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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