PharmaZell Group is pleased to announce that the US Food and Drug Administration has granted approval of Breckenridge Pharmaceutical, Inc. Abbreviated New Drug Application for Teriflunomide 7mg & 14mg Tablets (generic for Aubagio®) on September 24, 2021.
This product was developed by PharmaZell in collaboration with Breckenridge. The received FDA approval will allow Breckenridge, based on a Settlement Agreement with Sanofi Aventis LLC, to launch generic Teriflunomide in the US market from beginning of 2023 onwards while outside the USA PharmaZell is able to offer Licensing Agreements for Teriflunomide Tablets to interested customers. In addition this approval confirms another high quality API development which PharmaZell is able to promote as an attractive supply option to all interested customers world-wide.
Overall Teriflunomide presents a new member of PharmaZell’s focused portfolio of small molecule APIs which in combination with Custom Development and Manufacturing Services supports its dedication to service, on-time delivery, reliable supply and quality manufacturing.