Alembic Pharmaceuticals Limited has secured final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP, available in strengths of 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg.
The approved ANDA is therapeutically equivalent to Bausch Health US, LLC’s Cardizem CD Extended-Release Capsules. Diltiazem hydrochloride is prescribed for the treatment of hypertension, and may be used alone or with other antihypertensive medications. It is also indicated for the management of chronic stable angina and angina due to coronary artery spasm.
Market data indicates a substantial demand for Diltiazem Hydrochloride Extended-Release Capsules, with an estimated market size of US$105.3 million for the twelve months ending in June 2024, according to IQVIA.
With this approval, Alembic Pharmaceuticals now holds a total of 218 ANDA approvals from the USFDA, comprising 191 final approvals and 27 tentative approvals, marking a significant milestone for the company's presence in the US pharmaceutical market.
