Alembic Pharma Gets USFDA Nod for Generic Hypertension Treatment

New Delhi, Nov 11 (PTI) Alembic Pharmaceuticals Ltd on Monday said it has received final approval from the US health regulator for its generic Diltiazem Hydrochloride extended-release capsules indicated for the treatment of hypertension.

The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules of strengths 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg, Alembic Pharmaceuticals Ltd (Alembic) said in a statement.

These capsules are indicated for the treatment of hypertension. These capsules may be used alone or in combination with other antihypertensive medications.

Moreover, Diltiazem Hydrochloride is also indicated for the management of chronic stable angina and angina due to coronary artery spasm, the company said.

Diltiazem Hydrochloride extended-release capsules 120 mg, 180 mg, 240 mg, 300 mg, and 360 mg have an estimated market size of USD 105.3 million for the 12 months ended June 2024, the company said citing IQVIA data.