Granules India arm gets USFDA nod for insomnia tablets

Drug firm Granules India on Saturday said its US-based subsidiary has received approval from the US health regulator for its Ramelteon tablets used for treatment of insomnia. According to IQVIA Health data, Ramelteon tablets had US sales of around USD 33 million moving annual total (MAT) for the 12 months ended June 2020, Granules India said.

Drug firm Granules India on Saturday said its US-based subsidiary has received approval from the US health regulator for its Ramelteon tablets used for the treatment of insomnia. The United States Food & Drug Administration (USFDA) has approved the abbreviated new drug application (ANDA) filed by Granules Pharmaceuticals Inc for Ramelteon tablets, 8 mg, Granules India said in a filing to BSE.

The product is a generic version of Takeda Pharmaceuticals USA, Inc's Rozerem tablets in the same strength, it added. According to IQVIA Health data, Ramelteon tablets had US sales of around USD 33 million moving annual total (MAT) for the 12 months ended June 2020, Granules India said. The tablets are used for the treatment of insomnia characterized by difficulty with sleep onset, it added. The company now has a total of 29 ANDA approvals from USFDA (27 final approvals and 2 tentative approvals), Granules India said.