HIV Drug Gets Final FDA Approval

Article

Tenofovir disoproxil fumarate tablets treat HIV-1 infection in adults and pediatric patients ages 12 years and older.

The FDA announced that it granted final approval for an Abbreviated New Drug Application (ANDA) for tenofovir disoproxil fumarate 300-mg tablets for the treatment of HIV-1 infection in adults and pediatric patients ages 12 years and older.

The therapy is indicated to be used in conjunction with other antiretroviral agents and can begin marketing in the US immediately following the approval. It is a generic version of Gilead Sciences’ Viread, which was originally approved in October 2001, and utilized clinical data from the bioequivalent therapy for its FDA approval.

The Gilead product has reportedly brought in $725 million in sales for the 12-month period ending in November 2017, according to IMS Health. Cipla stated that it “is excited to add this important antiretroviral product to its growing portfolio of [antiretroviral therapies] in the US,” in a statement.

Several generics of the Gilead product have since been explored, the first generic version of the Gilead product coming from Teva Pharmaceuticals in late 2017.

Cipla, which has seen multiple generic approvals in the US in recent years, originally gained a foothold in the US market with the 2016 acquisition of InvaGen Pharmaceuticals and Exelan Pharmaceuticals. Since then, Cipla has been granted approval for 9 generics, including decitabine injection (Dacogen), budesonide inhalation suspension (Pumicort Respules), sevelamer carbonate (Renvela), abacavir/lamivudine (Epzicom), fenofibrate (Tricor), and entecavir (Baraclude), among others.

This article was originally published by MD Magazine.

Related Videos
male pharmacist using digital tablet during inventory in pharmacy | Image Credit: sofiko14 - stock.adobe.com
Pharmacist holding medicine box in pharmacy drugstore. | Image Credit: I Viewfinder - stock.adobe.com
Pharmacy Drugstore Checkout Cashier Counter | Image Credit: Gorodenkoff - stock.adobe.com
Medicine tablets on counting tray with counting spatula at pharmacy | Image Credit: sutlafk - stock.adobe.com
Capsules medicine and white medicine bottles on table | Image Credit: Satawat - stock.adobe.com
Human cell or Embryonic stem cell microscope background | Image Credit: Anusorn - stock.adobe.com
Concept of health care, pharmaceutical business, drug prices, pharmacy, medicine and economics | Image Credit: Oleg - stock.adobe.com
Biosimilar pharmaceutical drug bottle on blue background. | Image Credit: Carl - stock.adobe.com
© 2024 MJH Life Sciences

All rights reserved.