Leiner
Private labeler to begin shipping generic famotidine 10 mg, marketed under ANDA approval granted to Dr. Reddy's Labs, by Oct. 1. Dr. Reddy's ANDA 75-758 for J&J/Merck Pepcid AC equivalent received FDA clearance Aug. 17; Leiner currently markets generic ranitidine 75 mg (Pfizer/Warner-Lambert's Zantac 75) for Dr. Reddy's. Leiner joins Perrigo (marketing under a license from Teva) and Ivax in OTC generic famotidine market (1"The Tan Sheet" Aug. 6, In Brief)
More from Archive
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.’
More from Pink Sheet
While the first six months of the year saw eight new drugs targeting a range of diseases enter the European Medicines Agency’s priority medicines scheme, and three PRIME-designated treatments go on to win EU marketing approval, use of the accelerated assessment mechanism appears to be limited.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
The transparency initiative collects CRLs already made public in approval packages on its drugs@fda site to post on the openFDA public portal.