FDA Issues Reminder of Non-Substitution of PEDMARK® (sodium thiosulfate injection) for Pediatric Patients Receiving Cisplatin
Fennec Pharmaceuticals Inc. (FENC)
Last fennec pharmaceuticals inc. earnings: 11/12 06:00 am
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Source: GlobeNewswire
RESEARCH TRIANGLE PARK, N.C., Feb. 01, 2024 (GLOBE NEWSWIRE) -- Fennec Pharmaceuticals Inc. (NASDAQ: FENC; TSX: FRX), a commercial stage specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has issued a public reminder to healthcare providers that PEDMARK (sodium thiosulfate injection) is not substitutable with other sodium thiosulfate products as explicitly directed in its prescribing label. PEDMARK is the first and only FDA approved therapy indicated to reduce the risk of ototoxicity (e.g., permanent hearing loss) associated with cisplatin in pediatric patients 1 month of age and older with localized, non-metastatic solid tumors. The FDA stated in the public communication that it is aware that some providers may be preparing other sodium thiosulfate (STS) products for patient use in place of PEDMARK, including diluting STS products approved for other uses to match the strength of PEDMARK. The FDA reminded health care providers tha
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FENC
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- 3/21/24 - Miss
FENC
Sec Filings
- 5/1/24 - Form 144
- 4/26/24 - Form 4/A
- 4/26/24 - Form 4/A
- FENC's page on the SEC website