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Cipla receives ANDA approval

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The US FDA has granted final approval for Tenofovir Disoproxil Fumarate Tablets

Cipla, a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients, announced that it 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 (US FDA) 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) 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 US.

The product will be available for commercial shipment in the US immediately. Viread Tablets, 300mg, had US sales of approximately $ 725 million for the 12-month period ending November 2017, as reported by IMS Health.

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