Alpharma ANDA (75-518) for private label version of Pharmacia & Upjohn's Rogaine Extra Strength for Men tentatively approved July 22. Three-year marketing exclusivity for P&U's 5% minoxidil topical solution expires Nov. 14, 2000. At a July 29 American Academy of Dermatology meeting, Marty Sawaya, MD, University of Miami, noted hair loss treatments undergoing clinical trials include 5% minoxidil for women, for which P&U previously has said clinical trials have not shown significant effects. "We hope that by early next year 5% minoxidil [for women] will gain approval so that we can offer more treatment options," Sawaya said
Join thousands of industry professionals who rely on Pink Sheet for daily insights
Already a subscriber?
Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
This is your final call to participate in the survey to better understand our subscribers’ content and delivery needs. The deadline is 20 September.
We are conducting a survey to better understand our subscribers’ content and delivery needs. If there are any changes you’d like to see in coverage topics, article format, or the method in which you access the Pink Sheet – or if you love it how it is – now is the time to have your voice heard.
A new pilot aims to take Brazil closer to ‘digital transformation.’
Kwabena Frimpong-Manso Opuni has been appointed as the new acting CEO of the Ghana Food and Drugs Authority, succeeding Delese Darko, who is now head of the Africa’s pan-continental medicines agency.
The Health Research Authority is working on a streamlined model for informed consent that maintains people’s trust.
The European Commission has published two new strategies on stockpiling that will improve the availability of critical medicines in times of crisis and reduce the EU’s dependance on suppliers outside the bloc.
