Unichem Laboratories Limited has received ANDA approval for its baclofen tablets, USP, 10 mg and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Lioresal (baclofen) tablets, 10 mg and 20 mg of Novartis Pharmaceuticals Corp.
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Baclofen tablets are indicated for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity.
The product will be commercialized from Unichem’s Ghaziabad plant.
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