21 October, 2024, Mumbai: Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg, of Allergan Sales LLC (Allergan). Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension. Diltiazem hydrochloride may be used alone or in combination with other antihypertensive medications, such as diuretics. It is also indicated for the management of chronic stable angina. Refer label for a detailed indication.
Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, and 240 mg have an estimated market size for twelve months ending June 2024 according to IQVIA.
Alembic has a cumulative total of 217 ANDA approvals (190 final approvals and 27 tentative approvals) from USFDA.
