Cipla receives USFDA’s approval for Generic Viread Tablets

29 Jan 2018 Evaluate

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.

The company’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) agents for the treatment of HIV -1 infection in adults and paediatric patients 12 years of age and older. Cipla is excited to add this important antiretroviral product to its growing portfolio of ARVs in the U.S.

The product will be available for commercial shipment in the U.S. immediately. Viread Tablets, 300mg, had U.S. sales of approximately $725M for the 12-month period ending November 2017.

Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio includes over 1500 products across wide range of therapeutic categories with one quality standard globally.

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