Alembic Pharmaceutic has secured final approval from the US Food and Drug Administration (USFDA) for its generic version of Diltiazem Hydrochloride extended-release capsules, which are primarily used to manage hypertension.
This approval from the USFDA pertains to the abbreviated new drug application (ANDA), which is the application used to approve generic drugs.
The Diltiazem Hydrochloride extended-release capsules in strengths of 120 mg, 180 mg, and 240 mg have received approval from the US FDA following the ANDA filing. And deemed therapeutically equivalent to Allergan Sales LLC's Dilacor XR Extended-Release Capsules.
Diltiazem Hydrochloride is effective in treating hypertension and can be prescribed alone or in combination in conjunction with other antihypertensive drugs, such as diuretics. It is also utilized in managing chronic stable angina.
According to IQVIA data cited by Alembic, the estimated market size for these capsules for the year ending June 2024 is approximately USD 28.2 million.
Further Alembic has a cumulative total of 217 ANDA approvals (190 final approvals and 27 tentative approvals) from the US FDA.
What are Extended-Release Capsules?
The type of modified-release formulation is designed to release the active ingredient of the medication slowly and consistently. These tablets are formulated to maintain steady levels of the medication in the bloodstream over extended periods.
Generally taken once a day, though some formulations might require dosing twice a day.
These are designed to provide the correct daily dosage.
The patient need not take many pills throughout the day.
Diltiazem Hydrochloride Extended-Release Capsules
Diltiazem is a calcium ion influx inhibitor. When compared to the Diltiazem hydrochloride tablets at a steady state, 95% of the drug is absorbed from the extended-release capsules.
Food doesn't affect the absorption.
Dose-dumping does not occur with Diltiazem Hydrochloride extended-release capsules, ensuring that the medication is released at a consistent rate without sudden spikes in dosage.
The apparent elimination half-life of Diltiazem Hydrochloride, whether after single or multiple dosing, ranges from 5 to 8 hours.
Diltiazem Hydrochloride is effective in treating hypertension and can be prescribed alone or in combination in conjunction with other antihypertensive drugs, such as diuretics. It is also utilized in managing chronic stable angina.
(Input From Various Sources)
(Rehash/Josna Lewis/MSM)