Alembic Pharmaceuticals has received an 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 $48 million for twelve months ending December 2017 according to IQVIA. The company has a cumulative total of 80 ANDA approvals (67 final approvals and 13 tentative approvals) from USFDA.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.