Cipher Receives “Approvable” Letter For CIP-Isotretinoin
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA letter appears to resolve questions about the appropriate pathway for the acne medication.
You may also be interested in...
Cipher To Appeal “Approvable” Letter for CIP-Isotretinoin
Toronto firm maintains agency’s request for additional clinical data has already been addressed in existing NDA package.
Cipher To Appeal “Approvable” Letter for CIP-Isotretinoin
Toronto firm maintains agency’s request for additional clinical data has already been addressed in existing NDA package.
Cipher CIP-Tramadol ER Will Not Need Alcohol Interaction Study
Cipher no longer needs to complete a Phase I trial to investigate a potential interaction between the once-daily sustained-release pain medication CIP-tramadol ER and high levels of alcohol, the firm said June 15