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EAST WINDSOR, N.J. – Aurobindo Pharma Limited has received final approval from U.S. Food and Drug Administration for its Abbreviated New Drug Application ramelteon tablets, 8mg. Aurobindo Pharma’s ramelteon tablets, are an AB-rated generic equivalent to the reference listed drug (RLD), ROZEREM Tablets manufactured by Takeda Pharmaceuticals USA.
Ramelteon tablets, are indicated as a treatment of insomnia characterized by difficulty with sleep onset.
Ramelteon tablets, has an estimated market size of US $20.6 million for the twelve months ending May 2023, as per IQVIA.
