Fennec Pharmaceuticals Inc., a specialty pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Pedmark (sodium thiosulfate injection) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month of age and older with localized, non-metastatic solid tumors.
- Pedmark is the first and only FDA-approved therapy Indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors, an area of previously significant unmet medical need.
- The safety and efficacy of Pedmark have not been established when administered following cisplatin infusions longer than 6 Pedmark may not reduce the risk of ototoxicity when administered following longer cisplatin infusions, because irreversible ototoxicity may have already occurred.
- For more information about product availability and patient support, please contact the Fennec HEARS™ program at 1-833-7Pedmark (1-833-773-3627) or visit fennecpharma.com.