USFDA Approval granted for Pitavastatin Tablets

The USFDA has granted USFDA approval for Lupin's Abbreviated New Drug Application for pitavastatin tablets, available in 1 mg, 2 mg, and 4 mg variants.

USFDA Drug product Approval
USFDA Approval

USFDA Approval

USFDA Approval: In the dynamic landscape of the pharmaceutical industry, Lupin Limited, a global pharma major based in Mumbai, India, has recently made waves with a significant announcement.

The United States Food and Drug Administration (USFDA) has granted USFDA approval for Lupin’s Abbreviated New Drug Application for pitavastatin tablets, available in 1 mg, 2 mg, and 4 mg variants.

This approval allows Lupin to market a generic equivalent of Livalo tablets, a product of Kowa Company Limited.

Understanding the USFDA Approval

The USFDA approval marks a pivotal moment for Lupin Limited, signifying a milestone in the company’s commitment to innovation and quality pharmaceuticals.

The generic version of Livalo tablets, pitavastatin, is now set to enter the market, offering an alternative for patients and healthcare providers.

Manufacturing Excellence at Lupin’s Pithampur Facility

Lupin’s Pithampur facility in India will be the hub for manufacturing pitavastatin tablets.

This facility has been a cornerstone of Lupin’s production capabilities, ensuring adherence to the highest quality standards.

The strategic location and state-of-the-art infrastructure make Pithampur an integral part of Lupin’s global manufacturing network.

Medical Indications for Pitavastatin Tablets

Pitavastatin tablets play a crucial role in cholesterol management, specifically in reducing low-density lipoprotein cholesterol (LDL-C).

The USFDA approval extends the usage of pitavastatin tablets to adults with primary hyperlipidemia and individuals, including pediatric patients aged 8 years and older, with heterozygous familial hypercholesterolemia (HeFH).

Addressing Critical Health Concerns

The expanded indications cater to a broader patient population, addressing prevalent health concerns related to hyperlipidemia.

With a focus on both adults and pediatric patients, Lupin’s pitavastatin tablets present a versatile solution in the management of cholesterol levels.

Market Impact and Lupin’s Position

The pharmaceutical market is highly competitive, and Lupin Limited has strategically positioned itself as an innovation-led player.

The estimated annual sales of pitavastatin tablets in the US, amounting to USD 298 million according to IQVIA MAT September 2023, underscore the market potential for this generic equivalent.

Lupin’s Global Presence

Headquartered in Mumbai, India, Lupin operates in over 100 markets, including the US, India, South Africa, Asia Pacific (APAC), Latin America (LATAM), Europe, and the Middle East.

This expansive global presence reflects Lupin’s commitment to providing healthcare solutions worldwide.

Looking to the Future

As Lupin Limited celebrates this USFDA approval, the focus remains on future endeavors and contributions to the pharmaceutical landscape.

The approval of pitavastatin tablets is not just a regulatory milestone but a testament to Lupin’s dedication to improving global health.


In conclusion, Lupin Limited’s USFDA approval for pitavastatin tablets marks a significant achievement in the pharmaceutical realm.

The expanded indications, coupled with the strategic manufacturing at the Pithampur facility, position Lupin as a key player in cholesterol management.

As the company continues to innovate and expand its global reach, Lupin remains at the forefront of the pharmaceutical industry, contributing to the well-being of diverse populations.

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.

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