What is the coverage status for new strengths or formulations of existing medications?
For purposes of the Indiana Medicaid Preferred Drug List, a ‘line extension’ of a drug product is a new strength, formulation, or dosage form of the chemical entity that was the subject of the original new drug application as approved by the Food and Drug Administration. The PDL status of such drugs is the same as the status of the chemical entity that was the subject of the new drug application, unless determined otherwise by the Therapeutics Committee and Drug Utilization Review Board.
