U.S. FDA approves Fennec’s hearing loss therapy – Reuters
Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo
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Sept 21 (Reuters) – The U.S. Food and Drug Administration has approved Fennec Pharmaceuticals Inc’s (FENC.O) intravenous therapy to prevent chemotherapy-induced hearing loss in children, according to the health regulator’s website.
The approval, posted on the regulator’s website late Tuesday, for Pedmark allows it to be used to reduce the risk of ototoxicity in children aged over one month who have undergone chemotherapy using the drug cisplatin.
Cisplatin is used in treating a range of cancers in children such as liver, bone and brain cancer, but can cause permanent hearing loss.
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Pedmark is now the only approved therapy to prevent cisplatin-induced hearing loss in the United States, with most patients opting for either cochlear implants or hearing aids.</…….
