Alembic Pharmaceuticals Limited said that the U.S. Food and Drug Administration(USFDA) has given it final approval on its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP in the 120 mg, 180 mg and 240 mg strengths. The approved product is therapeutically equivalent to Allergan Sales LLC's branded product Dilacor XR Extended-Release Capsules in the same dosage form.

Diltiazem Hydrochloride Extended-Release Capsules are used for the treatment of hypertension alone or with other antihypertensive drugs, such as diuretics. The drug is also indicated for chronic stable angina.

IQVIA's data suggests a market size of $28.2 million for the 12 months through June 2024 for the dosage forms of Diltiazem Hydrochloride Extended-Release Capsules.

This approval brings the cumulative count of ANDA approvals made by Alembic Pharmaceuticals to 217, wherein 190 are final approvals through the FDA and 27 are tentative approvals.