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 for Colchicine Tablets USP, 0.6 mg. It is bioequivalent to the reference listed drug product (RLD), Colcrys Tablets, 0.6 mg, of Takeda Pharmaceuticals USA, Inc. This marks the first Paragraph 4 application from Granules.
Colchicine Tablets are used for treatment of Familial Mediterranean Fever (FMF).
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