The federal medical safety agency said on Wednesday that the vaccine has undergone testing on over 29,000 patients worldwide.
The agency did not name the drug but the France-based Sanofi Pasteur identified the vaccine as Dengvaxia.
Mexico said the vaccine is aimed at people aged 9 to 45 and will be used in areas where the disease is endemic.
Globally, dengue is the fastest-growing mosquito-borne disease. The deadliest form of the disease kills 22,000 people per year, according to WHO.