Tentative OK from US FDA for Watson's rosuvastatin zinc tablets
US drugmaker Watson Pharmaceuticals (NYSE: WPI) says that its subsidiary, Watson Laboratories, has received tentative approval from the US Food and Drug Administration for its rosuvastatin zinc 5, 10, 20 and 40mg tablets.
Watson's rosuvastatin zinc tablets are a new salt form of Anglo-Swedish drug major AstraZeneca's (LSE: AZN) blockbuster cholesterol lowerer Crestor (rosuvastatin calcium) tablets, which generated global sales of $1.7 billion in the second quarter of this year, a rise of 15% year-on-year.
On July 15, 2010, Watson Laboratories filed a New Drug Application under Section 505(b)(2) of the Federal Food and Drug Cosmetic Act (FFDCA) with the FDA seeking approval to market rosuvastatin zinc 5, 10, 20 and 40 mg tablets.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
Free
7 day trial access
- All the news that moves the needle in pharma and biotech
- Exclusive features, podcasts, interviews, data analyses and commentary from our global network of life sciences reporters.
- Receive The Pharma Letter daily news bulletin, free forever.
Become a subscriber
£820
Or £77 per month
- Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
- Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
- Daily roundup of key events in pharma and biotech.
- Monthly in-depth briefings on Boardroom appointments and M&A news.
- Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Today's issue
Company Spotlight
More Features in Generics
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze