FDA approves generic TDF/3TC for use in the US

12 December 2018. Related: Antiretrovirals.

Simon Collins, HIV i-Base

On 27 November 2018 the FDA approved a generic combination tablet of tenofovir disoproxil fumarate plus lamivudine (TDF/3TC) tablets for use in the US. [1]

The indication is for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult and paediatric patients weighing at least 35 kg.

Approval is based on bioavailability results compared to original products.

This formulation is manufactured by the Korean company Celltrion with a brand name Temixys.

Although the list price has not been announced, Celltrion have said this will be priced at an affordable level for people in the US who are struggling to meet high cost of medication and insurance. [2]

This might also be relevant for people who are currently unable to access PrEP (for which this combination is not indicated).

In some countries, the molecular similarity between 3TC and FTC means that TDF/3TC might also be applicable for use as PrEP.

Numerous similar generic formulations have previously received tentative approval for use outside the US.

References

1. FDA list serve (27 November 2018).
   https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/211284s000lbl.pdf (PDF)
2. U.S. FDA approves Celltrion’s HIV-1 treatment Temixys. (19 November 2018).
   https://pulsenews.co.kr/view.php?year=2018&no=724614