J&J Topamax “approvable” for migraines
Executive Summary
Johnson & Johnson plans to respond around year-end to an Oct. 23 "approvable" letter for Topamax (topiramate) for the supplemental indication of prophylaxis of migraine headache. Final approval awaits additional analysis of safety data and labeling negotiations...
You may also be interested in...
Topamax approved for migraine prevention
Ortho-McNeil's anti-convulsant Topamax (topiramate) clears FDA Aug. 11 for supplemental indication of prophylaxis of migraine headaches in adults. The recommended daily dose for migraines is 100 mg administered in two divided doses. Topamax' twice-daily migraine prevention regimen may place the drug at a disadvantage to Abbott's Depakote ER (divalproex extended-release), which has once-daily dosing . Ortho-McNeil received an "approvable" letter for the migraine indication in October 2003 (1"The Pink Sheet" Nov. 24, 2003, In Brief)...
J&J Topamax “Dear Doctor” Letter Advises Metabolic Acidosis Monitoring
Physicians should periodically examine Topamax (topiramate) patients for metabolic acidosis, a Johnson & Johnson "Dear Health Care Professional" letter recommends
'Touchless Plants' To Virtually Trained Workforces - Indian Cos Share Digitalization Tips
Despite AI and digital analytics playing an increasing role in pharma, the industry lags others globally, a recent event heard. Meanwhile, top Indian players including Sun Pharma, Cipla and others shared what is driving their initiatives, ranging from a 'touchless factory' to virtual training and lessons learned along the way.
Need a specific report? 1000+ reports available
Buy Reports
Register for our free email digests: