That loud ticking noise must have been stressful for Ranbaxy executives yesterday. For most of the day, it appeared to the outside world the massive generic-Lipitor market opportunity was passing them by because the FDA hadn't OK'd the Ranbaxy generic, presumably because of uncleared GMP violations.
To make matters worse, the FDA issued and then recalled an announcement of its approval. The agency said the announcement had been issued in error, reports Reuters.
Then came the agency's 11th hour announcement of the atorvastatin approval, confirmed by Bloomberg. Both the FDA announcement and a release issued later by Ranbaxy noted the drug approval. The Ranbaxy release said also the company had launched the product in the U.S.
But neither mentioned the source of the drama: Whether and how the two had cleared up longstanding GMP violations at several facilities in both the U.S. and India.
Despite the omission, there's no mistaking the approval delay proves the value of keeping manufacturing operations in order and maintaining positive relations with the FDA. Hanging in the balance for Ranbaxy was a half year of market co-exclusivity shared with Watson Pharmaceuticals ($WPI). The financial impact of losing that co-exclusive time would have been incalculable, given the advantage of being first on the scene.
- here's the FDA announcement
- see the Ranbaxy release
- here's the Bloomberg story
- and the Reuters report
- and more
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