Fennec Pharmaceuticals Inc. (FENC) on Tuesday said the Food and Drug Administration granted Orphan Drug Exclusivity to Pedmark indicated for the treatment to reduce the risk of ototoxicity, or hearing loss, associated with cisplatin use in pediatric cancer patients.
Orphan Drug Exclusivity provides 7 years of market exclusivity for Pedmark starting from September 2022, when the drug was approved, till September 2029.
The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually.
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