Enhanced Isotretinoin Risk Management Plan To Commence In Mid-2005
This article was originally published in The Pink Sheet Daily
Executive Summary
The program will include central registry for patients, prescribers and dispensing pharmacies, an FDA "Talk Paper" says. Celgene licenses patents covering Thalomid STEPS risk management program to isotretinoin manufacturers.
You may also be interested in...
Barr’s Expanded Thalidomide ANDA Could Increase Likelihood Of A Marketed Generic
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.
Barr’s Expanded Thalidomide ANDA Could Increase Likelihood Of A Marketed Generic
Amended application includes 50 mg and 100 mg dosage forms, which are used in multiple myeloma.
Celgene Will Take Barr To Court Over Thalomid Patents
Barr filed an ANDA for thalidomide for erythema nodosum leprosum, although Celgene markets the drug more broadly for multiple myeloma.