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.

Alembic Pharmaceuticals Ltd周一表示，其用于治疗高血压的仿制药盐酸地尔硫卓缓释胶囊已获得美国卫生监管机构的最终批准。该公司在一份声明中表示，美国食品和药物管理局（USFDA）批准的缩写新药申请（ANDA）盐酸地尔硫卓缓释胶囊的强度分别为120 mg、180 mg和240 mg。

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. The drug may be used alone or in combination with other antihypertensive medications, such as diuretics.

盐酸地尔硫卓缓释胶囊适用于治疗高血压。该药物可以单独使用，也可以与其他抗高血压药物（如利尿剂）联合使用。

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 USD 28.2 million for 12 months ended June 2024.(You can now subscribe to our Economic Times WhatsApp channel)(You can now subscribe to our Economic Times WhatsApp channel).

该公司表示，它也适用于治疗慢性稳定型心绞痛。Alembic Pharma引用IQVIA数据称，截至2024年6月的12个月内，盐酸地尔硫卓缓释胶囊120 mg、180 mg和240 mg的市场规模估计为2820万美元。