Fennec Pharmaceuticals Inc, a company developing a drug to help prevent cisplatin-related hearing loss in children, announced that it expects the FDA to decline its marketing application for Pedmark, Reuters reported. The company’s shares fell 45%, according to the article.
According to Reuters, the company said that the “Food and Drug Administration (FDA) indicated that deficiencies have been identified following an inspection of the drug’s manufacturing facility.” This is the second time the FDA has declined the company’s application for Pedmark.
The drug is intended for use by children from 1 month-18 years who have used platinum-based chemotherapy to treat cancer. The chemotherapy can cause permanent hearing loss.
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