Alembic Pharmaceuticals gets USFDA approval for capsules to treat insomnia

Mumbai, November 27:

Alembic Pharmaceuticals Limited (Alembic) 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, company said in a filing with BSE. 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.