Reporting by Joseph Keenan
The FDA dealt another blow to Fennec Pharmaceuticals' attempt to market a drug to treat hearing loss in pediatric cancer patients. The agency issued a second complete response letter targeting manufacturing issues.
Following a recent preapproval inspection of its manufacturing facility, the regulatory agency noted “deficiencies have been identified” at the site, the company said. Details of the manufacturing problems weren’t disclosed, and Fennec said it will request a meeting with the agency once the official CRL is received.
In August 2020, the FDA declined to approve Pedmark for similar reasons. At the time, Fennec resubmitted its application, and....
Read the original article on Fierce Pharma here.
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