Ranbaxy’s Valsartan ANDA Wins FDA Approval After Lengthy Delay
This article was originally published in The Pink Sheet Daily
Executive Summary
Regulatory nod gives Ranbaxy green light to launch its generic version of Novartis’ Diovan with 180-day exclusivity; other ANDA holders may continue to challenge Ranbaxy’s hold on the market.
You may also be interested in...
Mylan vs. FDA (And Ranbaxy): Diovan Exclusivity Forfeiture Edition
In a suit against FDA, Mylan argues that Ranbaxy’s delay in getting tentative approval for its valsartan ANDA within 30 months of submission triggered forfeiture of its 180-day marketing exclusivity.
Companies Reveal Hurdles In Providing Drugs Via Expanded Access Programs
GSK, Stealth BioTherapeutics and Blueprint Medicines discuss the difficulties getting participation of physicians, the excessive cost of expanded access, and whether physicians should report research data.
Current Pathways For Rare Disease Drugs Are Not Optimal, US FDA’s Califf Says
Anticipating a ‘tsunami of therapies’ for rare diseases, commissioner says the agency will have to think of creative approaches and employ regulatory flexibility for them. FDA considers copying the oncology center’s Project Facilitate for expanded access to other diseases.