Alembic Pharma gets US FDA approval for insomnia treatment drug

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.