FDA Approves Generic TDF/3TC for Use in the U.S.

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

The indicationsis for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult and pediatric 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 U.S. 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 indications).

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 U.S.

References

  1. FDA list serve (27 November 2018).
    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

[Note from TheBodyPRO: This article was originally published by HIV i-Base on Nov. 28, 2018. We have cross-posted it with their permission.]