Printer Friendly

FDA approves generic Ambien.

The FDA recently approved the first generic versions of Ambien (zolpidem tartrate) immediate-release tablets. Zolpidem (ZOLE-pi-dem) tartrate is a sedative-hypnotic drug indicated for the short-term treatment of insomnia.

Zolpidem tartrate tablets in formulations of five milligrams and 10 milligrams are manufactured by multiple generic drug companies in the United States. The following 13 manufacturers have received FDA approval for zolpidem tartrate tablets: Mylan Pharmaceuticals Inc., TEVA Pharmaceuticals USA, Roxane Laboratories Inc., Watson Laboratories Inc., Ranbaxy Laboratories Ltd., Dr. Reddy's Laboratories Ltd., Apotex Inc., Synthon Pharmaceuticals inc., Genpharm Inc., Mutual Pharmaceutical Company Inc., Caraco Pharmaceutical Laboratories Ltd., Carlsbad Technology Inc., and Lek Pharmaceuticals.
COPYRIGHT 2007 Advantage Business Media
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2007 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Title Annotation:Industry News
Publication:Pharmaceutical Processing
Date:Jun 1, 2007
Words:102
Previous Article:FDA committee finds substantial evidence to support Advair 500/50 in reducing COPD exacerbations.
Next Article:AstraZeneca to begin construction of $100m R&D expansion.
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters