Watson 483
This article was originally published in The Tan Sheet
Executive Summary
Firm says it is taking appropriate steps to remedy FDA observations in a 483 good manufacturing practices report regarding laboratory test messages and documentation procedures after an inspection of its Corona, Calif. manufacturing plant March 31 through May 6. Watson recently received ANDA approval for 2 mg and 4 mg nicotine polacrilex gum, equivalent to GlaxoSmithKline's mint-flavored Nicorette (1"The Tan Sheet" Aug. 2, 2004, In Brief)...
You may also be interested in...
Watson
Firm receives ANDA approval for 2 mg and 4 mg formualtions of mint-flavored nicotine polacrilex gum, bioequivalent to GlaxoSmithKline's Nicorette Mint...
Investors Go Berserk For Viking, Putting It Top Of Q1 Winners
The top 10 biggest share price winners and losers in Q1 from Evaluate show the investor frenzy for obesity drugs continues, while companies with governance doubts see shareholders retreat.
EU Consults On What Constitutes Personal & Commercially Confidential Data In Marketing Applications
Based on their experience with dealing with requests for access to documents over the past 12 years, EU regulators have proposed updating their guideline that provides for a harmonized approach to protecting personal data and business secrets in marketing authorization applications.