Industry

USFDA Approval granted for this Generic Hypertension Medication

This recent USFDA approval of Losartan Pot. and Hydrochlorothiazide Tablets catapults Granules' total ANDA approvals to an impressive count of 60 from the USFDA

The Health Master

October 1, 2023

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USFDA Drug product Approval — USFDA Approval

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Last Updated on December 24, 2023 by The Health Master

USFDA Approval

In a significant development, Granules India Limited, a prominent player in the pharmaceutical industry, announced that it has received USFDA approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) concerning the blood pressure-lowering medication Losartan Potassium and Hydrochlorothiazide tablets.

These tablets come in strengths of 50 mg/12.5 mg, 100 mg/12.5 mg, and 100 mg/25 mg.

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Details of the Approval

Granules’ latest achievement signifies a major stride in their efforts to provide accessible healthcare solutions.

The newly approved medication, a generic equivalent of Organon LLC’s Hyzaar, not only effectively lowers blood pressure but also diminishes the risk of stroke in patients dealing with hypertension and left ventricular hypertrophy.

Market Potential and Estimates

As of July 2023, estimations place the annual market value for this drug at a substantial US$73 million.

This projection underscores the critical role this medication is poised to play in addressing the healthcare needs of a wide demographic.

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Granules’ Expanding Portfolio

This recent USFDA approval catapults Granules‘ total ANDA approvals to an impressive count of 60 from the USFDA.

Among these, 58 are final approvals, while the remaining two are tentative approvals.

This robust portfolio attests to Granules’ unwavering commitment to delivering high-quality, affordable pharmaceuticals to the market.

In-Depth Insight into Losartan Potassium and Hydrochlorothiazide Tablets

Mechanism of Action:
- The medication combines the effectiveness of Losartan Potassium and Hydrochlorothiazide to combat hypertension.
- Losartan potassium acts as an angiotensin II receptor antagonist, relaxing blood vessels and lowering blood pressure.
- Hydrochlorothiazide is a diuretic that eliminates excess salt and water from the body, further aiding in blood pressure regulation.
Clinical Significance:
- The drug not only addresses high blood pressure but also offers added protection by reducing the risk of strokes in patients grappling with hypertension and left ventricular hypertrophy.
Market Impact:
- The approval of Granules’ generic version provides an affordable alternative for patients, enhancing accessibility to this critical medication.

Future Prospects

Granules India Limited is poised for a promising future, fortified by this recent milestone.

The company’s commitment to excellence and its expanding portfolio of FDA-approved medications position it as a key player in the global pharmaceutical landscape.

Insights into the USFDA Drug Approval Process:

1. Regulatory Affairs Consulting:

Essential for navigating the complex landscape of USFDA approvals.
Ensures adherence to stringent regulatory guidelines.

2. USFDA Drug Approval Process:

A meticulous process involving rigorous evaluation of safety and efficacy.
Demands comprehensive documentation and compliance with USFDA standards.

3. Generic Drug Approval Pathway:

An economical alternative to brand-name drugs, requiring a robust Abbreviated New Drug Application (ANDA).
Necessitates a thorough demonstration of bioequivalence.

4. USFDA Expedited Programs:

Designed to accelerate the approval process for drugs addressing unmet medical needs.
Includes Fast Track Designation, Breakthrough Therapy Designation, Priority Review Process, and Accelerated Approval Process.

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.