Science
Anti-inflammatory corticosteroid
What is Prednisone?
New Drug Approval (NDA) and Abbreviated New Drug Application (ANDA)
What is the drug approval pathways for Prednisone?
Inflammation, allergies, skin problems, and auto-immune diseases
What is Prednisone indicated for?
Orally
How is the Prednisone delivered?
First approved in US in 1955 by Pharmacia & Upjohn Co for brand name Deltasone, approved before modern IND/NDA structure
What is the drug history of Prednisone?
Indications and usage, available formulations, dosage and administration, contraindications, warnings and precautions, adverse reactions, drug-drug interactions, and how to store.
What is the key clinical information on the package insert for Prednisone?
1, 2.5, 5, 10, 20, 50 mg
What is the doses of Prednisone?
New Drug Approval Pathway for Deltasone Abbreviated New Drug Approval Pathway for generics
Through which approval pathway was Prednisone approved?
Advil and Warfarin
What is drug-drug interactions for Prednisone?
100-400 ng/mL
What is the plasma concentration of Prednisone with the normal dosing regimen?
Prednisone (Deltasone)'s approval (1955) predates the now more stringent regulations
How was the drug development process regulated for Prednisone?
pathophysiology, clinical presentation, in depth treatment/management options, and diagnosis
What key information is included in the guideline for the disease Prednisone treats?
CYP3A4 inducers will decrease Prednisone concentrations, while strong CYP3A4 inhibitors will increase concentrations.
How does Prednisone interact with other drugs?
Updated in 2006, SPL and PLR requirements were added based on drug tapering, safety precautions, and contraindications.
What regulatory limitations were placed on Prednisone post-marketing surveillance?
Prednisone is quickly metabolized and absorbed leading to faster effects and relief compared to other drugs
What benefits or safety issues does Prednisone have compared to other drugs for this condition?