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Ranbaxy recalls epilepsy drug in the US

Our Bureau,

New Delhi, Nov. 16 Ranbaxy Laboratories has said that it has recalled its Gabapentin tablets, the epilepsy and neuropathic pain-relief drug in the US.

Ranbaxy said that it was “carrying out a voluntary recall of all lots of its 600 mg and 800 mg Gabapentin tablets at the retail level as it found the presence of ‘related substances’ permitted in the products to be outside the approved specification limit.” The company is reportedly recalling 73 million tablets ‘voluntarily’ after discovering impurities beyond specified limits.

An analyst, who asked not to be named, said although it was an embarrassment in the short term, in the long run it would not have lasting effect on either revenues or image. Innovator companies which have found it hard to swallow the growing strengths of generic makers, such as Ranbaxy, which have over the last few years managed to make successful patent challenges, might not let go of this opportunity, he adds.

In September 2005, when Ranbaxy received US Food and Drug Administration’s approval for two strengths 600 and 800, it had estimated sales of the drugs at $964 million. Generic competition caused sales of Neurontin ($1.2 billion in 2004) to fall to $91million in the first half of 2005. Pfizer the innovator company in this case recently received a favourable judgment against generic copies of its now-off patent drug Neurontin.

More Stories on : Standards & Benchmarks | Announcements | Ranbaxy Laboratories Ltd | Pharmaceuticals

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