Granules Pharma gets USFDA nod for genetic disorder drug Colchicine

"The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a wholly-owned foreign subsidiary of Granules India Ltd for Colchicine tablets USP, 0.6 mg," the company said in a regulatory filing.

New Delhi: Granules India on Thursday said its wholly-owned foreign arm has received US health regulator's approval for Colchicine tablets, used in the treatment of familial Mediterranean fever.

Familial Mediterranean fever is a genetic disorder that causes recurrent episodes of fever that are typically accompanied by pain in the abdomen, chest, or joints.

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"The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, Inc, a wholly-owned foreign subsidiary of Granules India Ltd for Colchicine tablets USP, 0.6 mg," the company said in a regulatory filing.

The filing further said that "it is bioequivalent to the reference listed drug product (RLD), Colcrys tablets, 0.6 mg, of Takeda Pharmaceuticals USA, Inc."

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