MCA reclassification
This article was originally published in The Tan Sheet
Executive Summary
First two products to be considered under Medicines Control Agency's new drug reclassification system are J&J Consumer Pharmaceuticals' Nizoral Dandruff Shampoo 2% (ketoconazole) and Pharmacia's Regaine Regular Strength (minoxidil 2%). Firms have applied to switch legal status from "Pharmacy" to "General Sale List," MCA says. J&J's Nizoral switched from Rx to pharmacy status in 1996; indications will be for "prevention and treatment of dandruff only," UK agency says. Pharmacia's Regaine will have "improved information on the pack, label and leaflet," as well as dedicated hot line, Web site. New reclassification strategy went into effect April 1 (1"The Tan Sheet" May 6, 2002, p. 4)...You may also be interested in...
UK Drug Reclassification System May Double OTC Switches – Health Minister
The British government expects its new drug reclassification system to potentially double the number of medicines that switch from prescription to non-Rx status
Roche Continues To Make The Case For Gantenerumab In Alzheimer’s Disease
The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.
Brinavess' US Review: EU Postmarket Data Unlikely To Save Troubled AFib Drug
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.
Existing Subscriber?
Sign in to continue reading.
Need a specific report? 1000+ reports available
Buy Reports
Need a specific report? 1000+ reports available
Buy Reports
New to Pink Sheet?
Start a free trial today!
Register for our free email digests:
Register for our free email digests: