Global 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 used for the treatment of HIV-1 infections in adults. Cipla in a BSE filing said it has received final approval from the United States Food and Drug Administration (USFDA) for tenofovir disoproxil fumarate tablets, 300mg.
These tablets are AB-rated generic equivalents of Gilead Sciences’ Viread Tablets, 300 mg, and are shown in combination with other antiretroviral agents for the treatment of HIV – 1 infection in adults and pediatric patients 12 years old and older. Cipla is eager to add this important antiretroviral product to its growing portfolio of ARVs in the US.
Strides Shasun, which already had tentative approval for the product from the USFDA, said it will launch the product immediately. Citing to IMS deals information, the organization said the US market for tenofovir disoproxil fumarate tablets is around $750 million for the year time period ending November 2017, as detailed by IMS Health.
While delivering a long-term sustainable business, Cipla perceives its duty to provide affordable medications.
Cipla’s emphasis on access for patients was perceived globally for the pioneering role played in HIV/AIDS treatment as the first pharmaceutical company to provide a triple combination anti-retroviral (ARV) in Africa at less than a dollar a day and in this manner treating a large number of patients since 2001.
Cipla’s research and development focuses on developing inventive products and drug delivery systems.
Cipla is a global pharmaceutical company which utilizes cutting edge technology and innovation to meet the everyday needs of all patients. The company’s portfolio incorporates more than 1500 products crosswise over an extensive range of therapeutic categories with one quality standard globally.