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Generic Novartis MS drug approved
18 Aug 2006
Regulatory Affairs
In a further regulatory blow to Novartis, the US Food and Drug Administration (FDA) has given final approval to Caraco Pharmaceutical's application to sell a generic multiple sclerosis (MS) drug.
Baclofen, a generic version of Novartis' Lioresal, is a muscle relaxant that is used to treat the spasticity symptomatic of MS.
The Detroit-based firm will sell the treatment as tablets in 10 mg and 20 mg versions, and intends to launch the product "immediately".
Daniel Movens, chief executive officer of Caraco, said of the ruling: "We are pleased the FDA granted us another swift approval during this quarter, adding value to our portfolio of products we market in the US.
"This approval marks the third approval in the current quarter, two within the last 30 days," he added.
Caraco now markets 23 products available at different strengths.
Novartis, a Swiss company, claims to be the only company which leads globally in both branded and generic treatments, which it runs through its German subsidiary Sandoz.
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