11th November 2024, Bengaluru: Alembic Pharmaceuticals Limited (Alembic) announced that it has received Final Approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Cardizem CD Extended-Release Capsules, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, of Bausch Health US, LLC. 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. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm. Refer label for a detailed indication.
Diltiazem Hydrochloride Extended-Release Capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of US$105.3 million for twelve months ending June 2024 according to IQVIA.
Alembic has a cumulative total of 218 ANDA approvals (191 final approvals and 27 tentative approvals) from USFDA.
