(Reuters) – BioMarin Pharmaceutical, (NASDAQ:) Inc has received approval from the U.S. Health regulator Friday for its once-daily treatment for dwarfism in children. This makes it the first country-approved therapy for achondroplasia.

Voxzogo was approved by European regulators. It is intended for children 5 and up.

Achondroplasia is a rare condition that causes short stature in newborns. It’s currently not recognized in many countries.

BioMarin anticipates that the therapy will generate approximately $240,000 per year in net revenues in the United States. It also expects around 3,000 children to become eligible. Voxzogo, which is available at $899 per vial in the United States, will likely be on the market by December mid-to late.

BioMarin’s Voxzogo late-stage study demonstrated improvements in patient growth rates over one year. It was also well received. This drug has been approved for use in Europe by two-year-olds and older.

In April, the U.S. Food and Drug Administration extended its review by three months in order to evaluate two-year data.

The drug has been cleared under the expedited approval pathway. This requires that the drug be subject to a post-marketing assessment, which will assess the final adult height.

BioMarin indicated that they would be using the ongoing extensions studies results to get final approval.

BioMarin also stated that approval could be granted in Australia, Brazil, Japan, and Brazil next year.