Posted by Michael Wonder on 06 Aug 2021
Spectrum Pharmaceuticals receives complete response letter from FDA for Rolontis (eflapegrastim)
6 August 2021 - Spectrum Pharmaceuticals today announced receipt of a complete response letter from the U.S. FDA regarding the company’s biologics license application for Rolontis (eflapegrastim).
The letter cited deficiencies related to manufacturing and indicated that a re-inspection will be necessary.
The company is seeking further clarification from the FDA and plans to meet with the agency as soon as possible.
