Alembic Pharma's USFDA Nod: A Breakthrough in Hypertension Treatment

Alembic Pharmaceuticals has attained final approval from the USFDA for its generic Diltiazem Hydrochloride extended-release capsules, used to treat hypertension. The approval covers strengths of 120 mg, 180 mg, and 240 mg, equivalent to Allergan's Dilacor XR. The capsules' market size is valued at USD 28.2 million.

Alembic Pharmaceuticals Ltd announced on Monday that it has secured final approval from the US Food & Drug Administration (USFDA) for its generic version of Diltiazem Hydrochloride extended-release capsules. These capsules are utilized in the treatment of hypertension.

The approval pertains to Alembic's abbreviated new drug application (ANDA) for Diltiazem Hydrochloride capsules, which are available in strengths of 120 mg, 180 mg, and 240 mg. These are therapeutically equivalent to Allergan Sales LLC's Dilacor XR Extended-Release Capsules.

These capsules are intended for the treatment of hypertension and can be either used alone or combined with other antihypertensive medications. According to IQVIA data, these capsules have an estimated market size of USD 28.2 million for the year ending June 2024.

(With inputs from agencies.)