Dulera (formoterol fumarate, mometasone furoate)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS Clinical Trials Experience Pediatrics (additional section
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS Post-marketing Experience Immune System Disorders: Hypersensitivity
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 USE IN SPECIFIC POPULATIONS PLLR Conversion: Pregnancy Risk
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 PLR Conversion; please refer to label. ADVERSE REACTIONS
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Hepatotoxicity Assess LFTs prior to
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Risk of Extravasation and Tissue
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 ADVERSE REACTIONS The following serious adverse reactions are
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Ketoacidosis (addition of the following
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) July 2016 WARNINGS AND PRECAUTIONS Ketoacidosis (addition of the following