Barcelona, Spain-based Pharmadiet, SLU, a subsidiary of OPKO Health, Inc. has received regulatory approval from Spain's health authority (Agencia Española de Medicamentos y Productos Sanitarios) for commercialisation of its oral and injectable formulations of citicoline. The final marketing authorization is expected within 60 to 90 days.

Sales of the other citicoline product presently available in Spain, Somazina, exceeded $80 million in 2012. Citicoline also enjoys strong sales throughout Latin America, including those countries where OPKO maintains a growing presence.

"OPKO plans to commercialise its oral and injectable citicoline products in Europe, Latin America, and other markets as well," said Phillip Frost, MD, OPKO's chairman and chief executive officer.

Citicoline products are indicated for the treatment of memory disorders and behavior related to stroke, head injury, chronic disease, as well as degenerative brain disorders. Citicoline enhances the level of phosphatidylcholine in the brain.

Opko Health Inc. is a multi-national biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large and rapidly growing medical markets by leveraging our discovery, development and commercialization expertise and our novel and proprietary technologies.