FDA lifts approvals hold on Pliva facilities
The FDA granted final approval for the company’s azithromycin for oral suspension, a generic version of Pfizer’s antibiotic Zithromax, and warfarin sodium tablets, a generic version of Bristol-Myers
The European Commission (EC) has granted orphan designation to Lundbeck’s investigational monoclonal antibody asedebart (Lu AG13909) for the treatment of Cushing’s syndrome of endogenous origin.