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Cipla receives final approval for generic Epzicom tablets

Our Bureau, Mumbai
Tuesday, April 4, 2017, 16:45 Hrs  [IST]

Cipla Ltd, a global pharmaceutical company, 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 (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.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. In the last 80+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. The company’s portfolio includes over 1,000 products across wide range of therapeutic categories with one quality standard globally.


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