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Cipla receives US FDA approval for generic Epzicom tabs

financialexpressApril 06, 2017

Tag: cipla , FDA

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.

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