Novartis on Tuesday said it had received approval in Switzerland for Coartem Baby, which it said was the first drug to treat malaria in babies and young children.
Eight African countries that participated in the assessment are expected to issue quick approvals for the treatment, known as Riamet Baby in some countries.
Novartis launched Coartem to treat malaria in 1999, with a new dose strength designed for small babies.
The treatment is dissolvable, including in breast milk, and has a sweet cherry flavour to make it easier to administer.
There has been no approved malaria treatment for infants weighing less than 4.5kg, leaving a treatment gap, Novartis said.
The eight countries that took part in the assessment were Burkina Faso, Ivory Coast, Kenya, Malawi, Mozambique, Nigeria, Tanzania and Uganda.
About 30-million babies are born in areas of malaria risk in Africa every year, with one survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants younger than six months old, Novartis said.
Reuters
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