FDA Grants Final Approval to Tenofovir Disoproxil Fumarate Generic

JANUARY 29, 2018
Matt Hoffman
The US Food and Drug Administration (FDA) announced that it granted final approval for an Abbreviated New Drug Application (ANDA) for tenofovir disoproxil fumarate 300-mg tablets (Cipla Ltd) 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, Otuska America), budesonide inhalation suspension (Pumicort Respules, AstraZeneca), sevelamer carbonate (Renvela, Sanofi), abacavir/lamivudine (Epzicom, GlaxoSmithKline), fenofibrate (Tricor, AbbVie), and entecavir (Baraclude, Bristol-Myers Squibb), among others.

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