Granules Pharma receives USFDA approval for Ramelteon tablets

The US Food & Drug Administration (US FDA) has approved the Abbreviated New Drug Application (ANDA) filed by Granules Pharmaceuticals,

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Medicine Tablets
Picture: Pixabay

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.

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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.

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