Process validation is under way for Excedrin at the Novartis manufacturing facility in Lincoln, Nebraska, according to company CEO, Joseph Jimenez. That’s the good news.
The bad news for long-suffering devotees of this over-the-counter pain relief medicine is that the product will not be available in stores until October.
Jimenez gave this update during the Novartis 2nd Quarter conference call earlier today (July 19th). In addition to Excedrin, the company is in the process of product validation for Sentinel, a heartworm prevention pill. It, too, should ship before year-end.
Bad news for many pet owners is that Interceptor, a heartworm prevention pill that competes with Sentinel and also was manufactured at the same production facility, was not mentioned at all during Jimenez’s presentation. This does not bode well for its return to the marketplace in the near future. One San Diego veterinarian was told by his wholesale supplier not to expect Interceptor back on the market before 2013. The supplier’s representative explained that Sentinel, which contains the same active ingredient as Interceptor, is a higher margin product for Novartis and will have priority over the less profitable drug.
Novartis announced a massive product recall and was forced to halt production at the Lincoln plant in January 2012, as a result of packaging mixups and broken or chipped pills. An FDA inspection carried out in January found numerous repeat violations and deficiencies in the plant’s operations and quality control systems. It is taking the company several months longer than it originally hoped to address all of the issues listed in FDA’s 23-page long inspection report. But the end is apparently in sight.
Excedrin users will just have to hang on for a few more months…..