Last Updated on October 26, 2024 by The Health Master
USFDA
Alembic Pharmaceuticals, a leading global pharmaceutical company, has achieved a significant milestone with the US Food and Drug Administration (USFDA) granting final approval for its Abbreviated New Drug Application (ANDA) for Diltiazem Hydrochloride Extended-Release Capsules USP.
This approval marks a major step forward in providing patients with affordable and effective generic alternatives for hypertension and chronic stable angina treatment.
A Breakthrough in Generic Medication
The approved ANDA for Diltiazem Hydrochloride Extended-Release Capsules USP in 120 mg, 180 mg, and 240 mg formulations is therapeutically equivalent to the brand-name drug, Dilacor XR Extended-Release Capsules.
This means that it offers the same therapeutic benefits as the original product but at a potentially lower cost, making it more accessible to patients.
Addressing Cardiovascular Health Needs
Diltiazem Hydrochloride Extended-Release Capsules USP are indicated for the treatment of hypertension, a condition that affects millions of people worldwide.
These capsules can be used alone or in combination with other antihypertensive medications to effectively manage blood pressure.
Additionally, they are also approved for the management of chronic stable angina, a type of chest pain caused by reduced blood flow to the heart.
A Significant Market Opportunity
The estimated market size for Diltiazem Hydrochloride Extended-Release Capsules USP in the United States is substantial, reaching US$ 28.2 million for the twelve months ending June 2024.
This indicates a strong demand for this medication and presents a significant opportunity for Alembic Pharmaceuticals to expand its presence in the generic drug market.
Alembic’s Growing Portfolio
With this latest approval, Alembic Pharmaceuticals has further strengthened its position as a leading player in the generic pharmaceutical industry.
The company now has a cumulative total of 217 ANDA approvals from the USFDA, including 190 final approvals and 27 tentative approvals.
This impressive track record demonstrates Alembic’s commitment to providing high-quality, affordable generic medications to patients around the world.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
Disclaimer: This content, provides generic information only. It is in no way a substitute for a qualified medical opinion. Always consult a specialist or your own doctor for more information. The Health Master does not claim responsibility for this information.
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