Granules Pharmaceuticals, Inc gets USFDA nod for Colchicine tablets
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.
"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."
Disclaimer: No Business Standard Journalist was involved in creation of this content