Alembic Pharmaceuticals Ltd. announced it has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride extended-release capsules. The capsules, available in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, are indicated for the treatment of hypertension, chronic stable angina, and angina due to coronary artery spasm.
The approval allows Alembic to market a generic version of Diltiazem Hydrochloride, a calcium channel blocker commonly prescribed to manage hypertension. These capsules can be used alone or in combination with other antihypertensive medications, providing physicians with flexible treatment options. The company, citing IQVIA data, estimates the market size for Diltiazem Hydrochloride extended-release capsules at USD 105.3 million for the 12 months ending June 2024.
Diltiazem hydrochloride is a calcium channel blocker that works by relaxing blood vessels, making it easier for the heart to pump blood and reducing blood pressure. This mechanism also helps to alleviate chest pain (angina) by increasing blood supply to the heart. The availability of a generic option from Alembic Pharmaceuticals may offer a more affordable alternative for patients requiring this medication.
