Granules Pharmaceuticals, Inc. Receives USFDA nod for Colchicine pills

Granules Pharmaceuticals, Inc. Receives USFDA nod for Colchicine pills

by admin- Thursday, February 6th, 2020 03:45:57 PM

The US Food & Drug Administration (USFDA) has approved the Abbreviated New Drug Application (ANDA) filed through Granules Pharmaceuticals, Inc., an entirely owned foreign subsidiary of Granules India Ltd for Colchicine Tablets USP, zero.6 mg.

It is bioequivalent to the reference listed drug product (RLD), Colcrys Tablets, zero.6 mg, of Takeda Pharmaceuticals USA, Inc. This marks the first Paragraph 4 application from Granules.

Colchicine Tablets are used for remedy of Familial Mediterranean Fever (FMF).

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