sodium thiosulfate injection
for intravenous use Initial U.S. Approval: 1992
As specified in the prescribing information, sodium thiosulfate injection is indicated for the treatment of solid tumors (cancer). PEDMARK is indicated to reduce the risk of ototoxicity associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. Active ingredient: sodium thiosulfate anhydrous Inactive ingredients: boric acid. Sodium hydroxide and hydrochloric acid may have been used for pH adjustment. PEDMARK is a prescription medicine used to decrease the risk of hearing loss in children 1 month of age and older who are receiving cisplatin for solid tumors (cancer) that have not spread to other parts of the body.
Facts about sodium thiosulfate injection
Approval Date: 1992
Proprietary Name: PEDMARK (sodium thiosulfate injection)
Active Ingredient(s): sodium thiosulfate
FDA-approved use: solid tumors (cancer)
Dosage Form: Injection: 12.5 grams/100 mL in a single-dose via
Medicine Approved By: US FDA
Manufacturer: Fennec Pharmaceuticals, Inc
Summary of FDA-approved use on approval date: Click Here
(see Drugs@FDA for complete indication)
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Query For sodium thiosulfate injection
Approved accessible "sodium thiosulfate injection"
Pedmark (sodium thiosulfate) injection was initially approved in 2012 for cyanide poisoning. In 2022, CDER approved it to reduce the risk of hearing loss (ototoxicity) associated with cisplatin (a type of chemotherapy) in pediatric patients. It is the first treatment for this indication.
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PEDMARK (sodium thiosulfate injection), for intravenous use Initial U.S. Approval: 1992
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