The approved abbreviated new drug application (ANDA) is the therapeutic equivalent to the reference listed drug product (RLD) Restoril Capsules
Drug firm Alembic Pharmaceuticals has received approval from the US health regulator for Temazepam capsules, used for the treatment of insomnia.
The company has got approval from the US Food and Drug Administration (US FDA) to market the drug in the strength of 7.5mg, 15mg, 22.5mg and 40mg, Alembic Pharmaceuticals said in a BSE filing.
The approved abbreviated new drug application (ANDA) is the therapeutic equivalent to the reference listed drug product (RLD) Restoril Capsules.
Quoting IQVIA sales data, the company said, Temazepam capsules 7.5mg, 15mg, 22.5mg and 40mg had an estimated market size of $48 million for 12 months, ending December 2017.
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