Alembic Pharma gets USFDA nod
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
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New Delhi: 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 (USFDA) is for the abbreviated new drug application (ANDA) 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 (RLD), 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.
