Alembic Pharmaceuticals Receives US FDA Approval for Diltiazem Hydrochloride Extended-Release Capsules

Key Insights

• Alembic Pharmaceuticals has secured US FDA approval for Diltiazem Hydrochloride extended-release capsules (120 mg, 180 mg, 240 mg, 300 mg, and 360 mg).
• These capsules are indicated for the treatment of hypertension, and may be used alone or in combination with other antihypertensive medications.
• The approved ANDA is therapeutically equivalent to Cardizem CD extended-release capsules, offering a generic alternative for patients.

Alembic Pharmaceuticals Ltd. has received final approval from the US Food & Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride extended-release capsules USP, in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg. This approval provides a therapeutically equivalent generic option to Bausch Health US, LLC’s Cardizem CD extended-release capsules.

Diltiazem hydrochloride extended-release capsules are indicated for the treatment of hypertension. The medication can be prescribed as a standalone treatment or in conjunction with other antihypertensive drugs. Additionally, it is approved for managing chronic stable angina and angina resulting from coronary artery spasm. Healthcare professionals should refer to the product label for detailed prescribing information.

According to IQVIA data, the market size for Diltiazem hydrochloride extended-release capsules USP, 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg reached an estimated $105.3 million for the twelve-month period ending in June 2024. This approval marks a significant addition to Alembic's portfolio, bringing their total ANDA approvals from the US FDA to 218, comprising 191 final approvals and 27 tentative approvals.