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news.The FDA has granted final approval for Caraco Pharmaceutical's baclofen tablets, the company's generic version of Novartis' Lioresal, a muscle relaxant used for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis.
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Caraco’s baclofen tablets will be available in 10mg and 20mg strengths; the company said that it plans to release the product immediately.
“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,” said Daniel Movens, Caraco’s CEO.
Caraco was also recently granted final approval from the FDA to market a generic version of Boehringer Ingelheim’s anti-inflammatory, Mobic. Caraco received approval for this copycat product, which is used in the treatment of symptoms of osteoarthritis, in July.