USFDA nod for Granules insomnia tablets


The US Food and Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals Inc., a subsidiary of Granules India, for Ramelteon tablets, 8 mg.

The product is bio-equivalent to the reference listed drug product, Rozerem tablets 8 mg of Takeda Pharmaceuticals and are used to treat insomnia characterised by difficulty with sleep onset.

Ramelteon tablets had U.S. sales of approximately $33 million MAT for the 12 months ended June 2020, Granules said, citing IQVIA Health numbers.

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