Date: 25-Aug-2020

Granules Pharma Gets US FDA Approval For Generic Rozerem Tablets

Granules Pharmaceuticals, Inc (GPI)., a wholly owned foreign subsidiary of Granules India Limited has received US Food & Drug Administration (FDA) approval for ramelteon tablets, 8 mg.

It is bioequivalent to the reference listed drug product (RLD), Rozerem tablets, 8 mg, of Takeda Pharmaceuticals U.S.A., Inc.

Ramelteon tablets are used for the treatment of insomnia characterized by difficulty with sleep onset.

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

Granules now has a total of 29 ANDA approvals from US FDA (27 Final approvals and 2 tentative approvals)