Alembic Pharmaceuticals Limited has recently informed exchanges that it has obtained final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules, available in dosages of 120 mg, 180 mg, and 240 mg.
Diltiazem Hydrochloride Extended-Release Capsules are indicated for the treatment of hypertension and can be used alone or in combination with other antihypertensive agents, such as diuretics.
According to IQVIA, the estimated market size for Diltiazem Hydrochloride Extended-Release Capsules is projected to reach $28.2 million for the twelve months ending in June 2024. With this latest approval, Alembic has achieved a total of 217 ANDA approvals from the FDA, comprising 190 final approvals and 27 tentative approvals.