Warner-Lambert receives FDA approval March 8 for an efficacy supplement to NDA 20-745 for the labeled indication "For the prevention of heartburn, acid indigestion and sour stomach brought on by consuming food and beverages." The effervescent tablet (ranitidine 75 mg) was cleared Feb. 26, 1998 for heartburn treatment ("The Tan Sheet" March 2, 1998, p. 1). The launch of the product is still pending. Warner-Lambert may have been awaiting approval of the prevention indication before introducing the line extension to Zantac 75
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.’
Germany’s federal health care decision-making body, the G-BA, tells the Pink Sheet that German drug prices are fair and speculation of price rises in the market due to the US MFN policy is fear mongering.
EU marketing applications for drugs aimed at slowing myopia progression in children and for treating cutaneous T-cell lymphoma have been turned down by the European Medicines Agency.
In the infrequent cases when EU authorization precedes US FDA approvals of new products, biologics manufacturing issues are usually to blame, a Pink Sheet analysis found.
