Cipla receives final approval for Generic Viread tablets


Agencies, Mumbai Pharma Major,Cipla has received final approval for its abbreviated new drug application (ANDA) for Tenofovir Disoproxil Fumarate tablets, 300mg, from the United States Food and Drug Administration (USFDA) to market a generic version of Gilead Sciences’ Viread Tablets, 300mg. Cipla’s Tenofovir Disoproxil Fumarate Tablets, 300mg, are AB-rated generic equivalents of Gilead Sciences’ Viread Tablets, 300mg, and are indicated in combination with other antiretroviral (ARV) agentsfor the treatment of HIV -1 infection in adults and paediatric patients 12 years of age and older., company said in a filing with BSE. Cipla is excited to add this important antiretroviral product to its growing portfolio of ARVs in the US.The product will be available for commercial shipment in the U.S. immediately. Viread Tablets,300mg, had U.S. sales of approximately USD725 M for the 12-month period ending November 2017,as reported by IMS Health, filing added.

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