Zdrowie i gospodarka · 29/08/2018

DHL Laboratories Inc. Faces FDA Proposal to Withdraw Approval of Dextrose 5% Injection NDA

The FDA is proposing to withdraw approval of a new drug application for Dextrose 5% Injection in Plastic Container due to repeated failure to file required annual reports, and is offering the holder, DHL Laboratories Inc., the opportunity to request a hearing on the proposal.