Merck (MRK) Resubmits NDA for Ezetimibe, Atorvastatin Tabs
- Market Wrap: Initial Claims Show Modest Gain; GE Bring on Q1 Beat; Wal-mart Gets into Money-Transfer Game
- Streetinsider.com After-Hours Movers 04/17: (AMD) (SCSS) Higher; (ACTG) (AVGO) (ATHN) Lower
- Advanced Micro Devices, Inc. (AMD) Tops Q1 EPS by 2c; Sees Q2 Revs +/- 3% Q/Q
- General Electric (GE) Tops Q1 EPS by 1c
- athenahealth, Inc. (ATHN) Misses Q1 EPS by 5c
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.
You May Also Be Interested In
- UPDATE: Avago Tech (AVGO) Active Following Patent Case Ruling
- Spectrum Pharmaceuticals (SPPI) Appointed Joseph Turgeon as President and COO
- UPDATE: Gilead (GILD) Receives Orphan Status for Chronic Lymphocytic Leukemia Treatment
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!