First dolutegravir-based generic FDC gets FDA tentative approval

Polly Clayden, HIV i-Base

On 7 August 2017, the first generic dolutegravir-based fixed dose combination (FDC) by Mylan pharmaceuticals received tentative approval from the US FDA.

This is for a New Drug Application for dolutegravir, lamivudine and tenofovir disoproxil fumarate 50/300/300 mg tablets (TDF/3TC/DTG or TLD). [1]

TLD combines antiretrovirals from two originator manufacturers: ViiV Healthcare’s DTG and 3TC (via a license through the Medicines Patent Pool) and Gilead Science’s TDF.

TLD will be available as a first-line regimen for people with HIV in countries with access to generic ARVs.


This is groundbreaking news: global use of integrase-based ART needed not just generic dolutegravir but a generic FDC.

As of June 2017, more than 20 low- and middle-income countries have included or are planning to include DTG in their national guidelines. [2] Botswana and Brazil have started providing DTG nationwide and Kenya, has started a pilot programme of phased introduction (similar programmes are planned in Uganda and Nigeria). To date these early adopter countries have used either originator products (Brazil and Botswana) or more recently (Kenya being the first country to introduce generic DTG) as a single generic formulation plus 2 NRTIs. [3]

The WHO pre-qualification programme is also assessing this version of TLD with results expected at the end of the year. More submissions of DTG, both single and FDC formulations are expected over the next year or two. [4] By the end of 2017 DTG single is expected to be registered in 56 countries and DTG-based FDCs in 38 countries.

This version of TLD was notable for its swift tentative approval (it only took 6 months) and hopefully other products will follow suit. Then the time to obtain local registration (or a waiver) will be a hugely important factor for programmes transitioning to new DTG-based formulations. Increased availability of approved and/or prequalified generic FDCs will assure both price competition and supply security and will give national programmes confidence to make the transition.


  1. Mylan press release. Mylan Receives Tentative Approval for “TLD” Under PEPFAR. (7 August 2017).
  2. WHO. Transition to new antiretroviral drugs in HIV programmes: clinical and programmatic considerations. July 2017. (PDF)
  3. Unitaid press release. Kenya to introduce better treatment for people living with HIV. 28 June 2017.
  4. CHAI. ARV market report: the state of the antiretroviral market in low- and middle-income countries, 2015–2020. Issue 7, October 2017.

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