Alembic Pharma gets USFDA nod to Diltiazem Hydrochloride ER Capsules to treat hypertension
Mumbai: Drug maker Alembic Pharmaceuticals Ltd has recently announced that it has received final approval from the United States Food and Drug Administration (USFDA) for the abbreviated new drug application (ANDA) Diltiazem Hydrochloride extended-release capsules of strengths 120 mg, 180 mg, and 240 mg.
The approved ANDA is therapeutically equivalent to the reference listed drug, Dilacor XR Extended-Release Capsules (120 mg, 180 mg, and 240 mg), manufactured by Allergan Sales LLC, the company said in a statement.
Diltiazem Hydrochloride Extended-Release Capsules USP are prescribed for hypertension management and can be used alone or alongside other antihypertensive drugs, like diuretics. Additionally, they are indicated for managing chronic stable angina.
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According to IQVIA, the estimated market size for Diltiazem Hydrochloride Extended-Release Capsules USP (120 mg, 180 mg, and 240 mg) is $28.2 million for the twelve-month period ending June 2024.
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