Granules Pharma receives US FDA approval for Ramelteon tablets

The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals, a wholly-owned foreign subsidiary of Granules India for Ramelteon tablets, 8 mg. It is bioequivalent to the reference listed drug product (RLD), Rozerem tablets, 8 mg, of Takeda Pharmaceuticals USA. Ramelteon tablets are used for the treatment of insomnia characterised by difficulty with sleep onset.

Granules now has a total of 29 ANDA approvals from US FDA (27 final approvals and two tentative approvals).

Ramelteon tablets had US sales of approximately $33 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health.

Rozerem is a trademark of Takeda Pharmaceutical Company.