Alembic Pharma Obtains USFDA Approval for Hypertension and Angina Relief Capsules

Alembic Pharmaceuticals Limited has obtained final approval from the US Food and Drug Administration (USFDA) for its diltiazem hydrochloride extended-release capsules USP in strengths of 120 mg, 180 mg and 240 mg.

These capsules, used for the treatment of hypertension and chronic stable angina, are therapeutically equivalent to Allergan’s Dilacor XR extended-release capsules.

Diltiazem hydrochloride is indicated to control high blood pressure, either as a stand-alone treatment or in combination with other antihypertensive medications such as diuretics. It is also used in the treatment of chronic stable angina, offering relief to those suffering from chest pain related to heart conditions.

The estimated market size of diltiazem hydrochloride extended-release capsules in the US amounts to $28.2 million for the twelve months ending June 2024, according to IQVIA data. Alembic’s USFDA approval for these capsules further strengthens its US portfolio, bringing the company’s cumulative total of Abbreviated New Drug Application (ANDA) approvals to 217, of which 190 are approvals finals.

Source link

Disclaimer:
The information contained in this post is for general information purposes only. We make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability or availability with respect to the website or the information, products, services, or related graphics contained on the post for any purpose.
We respect the intellectual property rights of content creators. If you are the owner of any material featured on our website and have concerns about its use, please contact us. We are committed to addressing any copyright issues promptly and will remove any material within 2 days of receiving a request from the rightful owner.

Leave a Comment