Mylan committed to submitting LPV/r granules for regulatory approval in 2017; “4-in-1” (ABC/3TC/LPV/r) granules in 2018; and a paediatric ABC/3TC/DTG formulation in 2019, subject to the WHO providing paediatric DTG dosing guidance in early 2018.

Mylan

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Submit a paediatric ABC/3TC/DTG formulation in 2019, subject to the WHO providing paediatric DTG dosing guidance in early 2018.

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Development of this product will commence following finalization of WHO pediatric DTG dosing guidance, which is still pending.

 

Mylan’s development of this product has been pending final WHO guidance on its dosage; we do not currently have a target submission date, but the earliest it could be submitted would be Q4 2020.


Mono DTG under development with ViiV and through partnership with UNITAID.

 

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Submit “4-in-1” (ABC/3TC/LPV/r) granules in 2018

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Submission to WHO PQ and FDA now scheduled for Q2 2019.

 

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Submit LPV/r granules for regulatory approval in 2017

Mylan

Mylan submitted its pediatric LPV/r formulation to WHO PQ in December 2017.

Following WHO PQ submission in December 2017, LPV/r has been submitted to the GFATM ERP in January 2018  and to the FDA February 2018.

The product was tentatively approved by FDA under PEPFAR in August 2018. See https://www.fda.gov/internationalprograms/pepfar/ucm119231.htm.


Mylan is now scaling up production and in dialogue with PEPFAR and the Global Fund to ensure supply as soon as possible.

 

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Sub-Actions & Milestones

Updates

Notes

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