Breckenridge receives FDA OK for generic Aubagio

The Food and Drug Administration has green-lighted Breckenridge’s teriflunomide tablets.

The medication is the generic of Aubagio. It is used to treat relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.

[Read more: Breckenridge signs multiproduct agreement with Welding]

This product was developed in collaboration with PharmaZell GmbH, Germany.

Breckenridge received final approval for the 7 mg and 14 mg strengths.

[Read more: Breckenridge, Aggrega Pharma sign multiproduct agreement]

Sanofi Aventis and Breckenridge have entered into a settlement agreement that permits Breckenridge to launch its generic teriflunomide product on March 12, 2023.

Aubagio had a market value of approximately $1.9 billion during the 12 months ending July 2021, according to industry sales data.