Alembic Pharmaceuticals Gets US FDA Approval For Generic Diltiazem Capsules

Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic version of Diltiazem Hydrochloride extended-release capsules used to treat hypertension. The approval by the US Food & Drug Administration is for the abbreviated new drug application Diltiazem Hydrochloride extended-release capsules of strengths 120 mg, 180 mg, and 240 mg, the company said in a statement.

These are therapeutically equivalent to the reference listed drug product, Dilacor XR Extended-Release Capsules, 120 mg, 180 mg, and 240 mg of Allergan Sales LLC, it added.

Diltiazem Hydrochloride extended-release capsules are indicated for treatment of hypertension. The drug may be used alone or in combination with other antihypertensive medications, such as diuretics. It is also indicated for the management of chronic stable angina, the company said.

Citing IQVIA data, Alembic Pharma said Diltiazem Hydrochloride extended-release capsules 120 mg, 180 mg, and 240 mg have an estimated market size of $28.2 million for 12 months ended June 2024.