Alembic secures USFDA approval for Diltiazem Hydrochloride extended-release capsules

Alembic Pharmaceuticals (Alembic) has announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP in 120 mg, 180 mg, and 240 mg formulations.

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, manufactured by 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. The label provides a detailed indication.

Diltiazem Hydrochloride Extended-Release Capsules USP in the 120 mg, 180 mg, and 240 mg dosages have an estimated market size of US$ 28.2 million for the twelve months ending June 2024, according to IQVIA.

Alembic has a cumulative total of 217 ANDA approvals from the USFDA, which includes 190 final approvals and 27 tentative approvals.