Merck (MRK) Resubmits NDA for Ezetimibe, Atorvastatin Tabs
- Top 10 News for 4/13 - 4/17: China Regulation, Greek Debt Rattle Markets; Netflix Rockets on Results; M&A News, Rumors Abound
- U.S. Antitrust Lawyers May Move to Block Comcast (CMCSA), Time Warner Cable (TWC) Deal
- Teva (TEVA) Said Considering Bid for Mylan (MYL)
- General Electric (GE) Tops Q1 EPS by 1c
- Stock Futures Deep in the Red
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has acknowledged the resubmission of a New Drug Application (NDA) for ezetimibe and atorvastatin tablets, an investigational combination medicine. The updated NDA was deemed complete for review after Merck submitted additional data in response to the FDA’s Complete Response Letter issued last year. Merck expects the FDA’s review to be completed in the first half of 2013.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- Early Findings with KEYTRUDA® (pembrolizumab), Merck’s Anti-PD-1 Therapy, in Patients with Advanced Pleural Mesothelioma Presented at AACR Annual Meeting
- Mylan (MYL) Announces Favorable Decision in Perforomist Patent Infringement Appeal (TEVA)
- Sunshine Heart (SSH) Announces FDA Conclusion of COUNTER HF Review; Minor Protocol Changes Requested
Create E-mail Alert Related CategoriesCorporate News, FDA
Sign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!