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Aurobindo gets FDA approval for baclofen tablets

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EAST WINDSOR, N.J. – Aurobindo has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application baclofen tablets USP, 10 mg and 20 mg. Aurobindo Pharma’s baclofen tablets USP, 10 mg and 20 mg, are an AB-rated generic equivalent to the reference listed drug (RLD),Loiresal of Novartis Pharmaceuticals Corp.

Baclofen tablets are useful 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. Baclofen Tablets may also be of some value in patients with spinal cord injuries and other spinal chord diseases.

Baclofen tablets has an estimated market size of US $77 Million for the twelve months ending May 2021, as per IQVIA.


ECRM_06-01-22


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