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Aurobindo receives FDA approval for colchicine tablets

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EAST WINDSOR, N.J. – Aurobindo Pharma has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application colchicine tablets USP, 0.6 mg. Aurobindo Pharma’s colchicine tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), COLCRYS Tablets, of Takeda Pharmaceuticals USA, Inc.

Colchicine tablets are indicated in adults and children four years or older for treatment of familial Mediterranean fever (FMF).

Colchicine tablets has an estimated market size of US $111 million for the twelve months ending November 2021, as per IQVIA.


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