Alembic Pharmaceuticals announced that it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Restoril Capsules, 7.5mg, 15mg, 22.5mg and 40mg, of SpecGx LLC. Temazepam Capsules are indicated for short term treatment of insomnia.
Temazepam Capsules USP 7.5mg, 15mg, 22.5mg and 40mg have an estimated market size of USD 48 million for twelve months ending December 2017 according to IQVIA.
Alembic has a cumulative total of 80 ANDA approvals (67 final approvals and 13 tentative approvals) from USFDA.
Shares of the company declined Rs 5.15, or 0.92%, to trade at Rs 557.00. The total volume of shares traded was 3,696 at the BSE (3.22 p.m., Wednesday).