Canada’s AEterna Laboratories Inc. said on Tuesday that the US Food and Drug Administration (FDA) has granted its lead product, a compound extracted from the cartilage of sharks, orphan drug status for the treatment of renal cell carcinoma.
The FDA orphan drug designation entitles AEterna to receive seven-year exclusive marketing rights for that indication if the extract eventually is approved. It also permits AEterna to apply for research funding, tax credits and certain waivers from regulatory fees, as well as assistance from the FDA with the regulatory approval process.
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