Ellansé has never been approved in the United States. Obtaining FDA approval for fillers is generally more complex and expensive than approvals in Europe or Asia, and companies sometimes choose not to pursue the U.S. pathway for reasons unrelated to product quality. The decision may reflect the cost of the approval process, a limited remaining patent life, or prior communications with the FDA suggesting a challenging route to approval. Ultimately, only the manufacturer knows the specific reasons it was not brought to the U.S. market.
Dr.S